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53. Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction EMPEROR-Preserved Trial

Author

Packer, Milton Butler, Javed Zannad, Faiez Filippatos, Gerasimos Ferreira, Joao Pedro Pocock, Stuart J. Carson, Peter Anand, Inder Doehner, Wolfram Haass, Markus and Komajda, Michel Miller, Alan Pehrson, Steen Teerlink, John R. Schnaidt, Sven Zeller, Cordula Schnee, Janet M. and Anker, Stefan D. EMPEROR-Preserved Trial Study Grp

Abstract

BACKGROUND: Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction, but additional data are needed about its effect on inpatient and outpatient heart failure events. METHODS: We randomly assigned 5988 patients with class II through IV heart failure with an ejection fraction of >40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to usual therapy, for a median of 26 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite end points. RESULTS: Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.77 [95% CI, 0.67-0.87]; P40% to

Published
2021

54. Empagliflozin in Heart Failure with a Preserved Ejection Fraction

Author

Anker, Stefan D. Butler, Javed Filippatos, Gerasimos and Ferreira, Joao P. Bocchi, Edimar Boehm, Michael Brunner-La Rocca, Hans-Peter Choi, Dong-Ju Chopra, Vijay and Chuquiure-Valenzuela, Eduardo Giannetti, Nadia Gomez-Mesa, Juan Esteban Janssens, Stefan Januzzi, James L. and Gonzalez-Juanatey, Jose R. Merkely, Bela Nicholls, Stephen J. and Perrone, Sergio V. Pina, Ileana L. Ponikowski, Piotr and Senni, Michele Sim, David Spinar, Jindrich Squire, Iain and Taddei, Stefano Tsutsui, Hiroyuki Verma, Subodh Vinereanu, Dragos Zhang, Jian Carson, Peter Lam, Carolyn Su Ping and Marx, Nikolaus Zeller, Cordula Sattar, Naveed Jamal, Waheed and Schnaidt, Sven Schnee, Janet M. Brueckmann, Martina and Pocock, Stuart J. Zannad, Faiez Packer, Milton EMPEROR Preserved Trial

Abstract

BACKGROUND Sodium-glucose cotransporter 2 inhibitors reduce the risk of hospitalization for heart failure in patients with heart failure and a reduced ejection fraction, but their effects in patients with heart failure and a preserved ejection fraction are uncertain. METHODS In this double-blind trial, we randomly assigned 5988 patients with class II-IV heart failure and an ejection fraction of more than 40% to receive empagliflozin (10 mg once daily) or placebo, in addition to usual therapy. The primary outcome was a composite of cardiovascular death or hospitalization for heart failure. RESULTS Over a median of 26.2 months, a primary outcome event occurred in 415 of 2997 patients (13.8%) in the empagliflozin group and in 511 of 2991 patients (17.1%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.69 to 0.90; P

Published
2021

55. The Safety of an Adenosine A1-Receptor Antagonist, Rolofylline, in Patients with Acute Heart Failure and Renal Impairment: Findings from PROTECT

Author

Teerlink, John R., Iragui, Vicente J., Mohr, Jay P., Carson, Peter E., Hauptman, Paul J., Lovett, David H., Miller, Alan B., Piña, Ileana L., Thomson, Scott, Varosy, Paul D., Zile, Michael R., Cleland, John G. F., Givertz, Michael M., Metra, Marco, Ponikowski, Piotr, Voors, Adriaan A., Davison, Beth A., Cotter, Gad, Wolko, Denise, DeLucca, Paul, Salerno, Christina M., Mansoor, George A., Dittrich, Howard, O’Connor, Christopher M., and Massie, Barry M.

Published
2012
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57. Conduct of clinical trials in the era of COVID-19: JACC scientific expert panel

Author

Psotka, Mitchell A., Abraham, William T., Fiuzat, Mona, Filippatos, Gerasimos, Lindenfeld, JoAnn, Ahmad, Tariq, Bhatt, Ankeet S, Carson, Peter E, Cleland, John G.F., Felker, G Michael, Januzzi, James L, Kitzman, Dalane W, Leifer, Eric S, Lewis, Eldrin F, McMurray, John J.V., Mentz, Robert J, Solomon, Scott D, Stockbridge, Norman, Teerlink, John R, Vaduganathan, Muthiah, Vardeny, Orly, Whellan, David J, Wittes, Janet, Anker, Stefan D, and O'Connor, Christopher M

Subjects
R1
Abstract

The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment. The Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory and the Academic Research Consortium, composed of academic investigators from the United States and Europe, patients, the U.S. Food and Drug Administration, the National Institutes of Health, and industry members. A series of meetings were convened to address the challenges caused by the COVID-19 pandemic, review options for maintaining or altering best practices, and establish key recommendations for the conduct and analysis of clinical trials for cardiovascular disease and heart failure. This paper summarizes the discussions and expert consensus recommendations.

Published
2020

58. Omecamtiv mecarbil in chronic heart failure with reduced ejection fraction, GALACTIC‐HF: baseline characteristics and comparison with contemporary clinical trials

Author

Teerlink, John R., Diaz, Rafael, Felker, G. Michael, McMurray, John J.V., Metra, Marco, Solomon, Scott D., Adams, Kirkwood F., Anand, Inder, Arias‐Mendoza, Alexandra, Biering‐Sørensen, Tor, Böhm, Michael, Bonderman, Diana, Cleland, John G.F., Corbalan, Ramon, Crespo‐Leiro, Maria G., Dahlström, Ulf, Echeverria Correa, Luis E., Fang, James C., Filippatos, Gerasimos, Fonseca, Cândida, Goncalvesova, Eva, Goudev, Assen R., Howlett, Jonathan G., Lanfear, David E., Lund, Mayanna, Macdonald, Peter, Mareev, Vyacheslav, Momomura, Shin‐ichi, O'Meara, Eileen, Parkhomenko, Alexander, Ponikowski, Piotr, Ramires, Felix J. A., Serpytis, Pranas, Sliwa, Karen, Spinar, Jindrich, Suter, Thomas M., Tomcsanyi, Janos, Vandekerckhove, Hans, Vinereanu, Dragos, Voors, Adriaan A., Yilmaz, Mehmet B., Zannad, Faiez, Sharpsten, Lucie, Legg, Jason C., Abbasi, Siddique A., Varin, Claire, Malik, Fady I., Kurtz, Christopher E., Besada, Diego Alejandro, Majul, Claudio Rodolfo, Bruno, Marco Raul Litvak, Sassone, Sonia, Avaca, Horacio Alberto, Rasmussen, Mariela, Aiub, Jorge Roberto, Hominal, Miguel Angel, Perna, Eduardo, Duran, Ruben Omar Garcia, Schiavi, Lilia, Marquez, Lilia Luz Lobo, Vilamajo, Oscar Alberto Gomez, Mackinnon, Ignacio, Fuente, Ricardo Alfonso Leon, Montana, Oscar Romano, Novaretto, Leonardo, Guerrero, Rodolfo Andres Ahuad, Brasca, Daniela Garcia, Prado, Aldo, Garrido, Marcelo Alejandro, Luquez, Hugo, Martinez, Diego Felipe, Nicolosi, Liliana, Parody, Maria Leonor, Zaidman, Cesar, Berra, Fernando Colombo, Ibañez, Julio, Zapata, Gerardo, Caccavo, Alberto, Colque, Roberto, Diez, Mirta, Poy, Carlos, Salomone, Oscar Alejandro, Vogel, Daniel, Bordonava, Anselmo Paulino, Fernandez, Alberto, French, John, Atherton, John, Hamilton, Andrew, Begg, Alistair, Abhayaratna, Walter, Judkins, Christopher, De Pasquale, Carmine, McKenzie, Scott, Amerena, John, Szto, Gregory, Kearney, Leighton, Zimmet, Hendrik, Sverdlov, Aaron, Beltrame, John, Korczyk, Dariusz, Sindone, Andrew, Moertl, Deddo, Huber, Kurt, Huelsmann, Martin, Ablasser, Klemens, Ebner, Christian, Siostrzonek, Peter, Drexel, Heinz, Poelzl, Gerhard, Dujardin, Karl, Dupont, Matthias, Buysschaert, Ian, Lancellotti, Patrizio, Droogne, Walter, Chouchane, Iman, Silveira, Fabio, Rassi, Salvador, Reis, Gilmar, Filho, Pedro Pimentel, Simoes, Marcus Vinicius, Braga, Joao Carlos, Giorgeto, Flavio Eduardo, Ferraz, Almir, Jaeger, Cristiano Pederneiras, Saraiva, Jose Francisco, Tognon, Alexandre, Cardoso, Juliano, Greco, Oswaldo, Paiva, Maria Sanali, Paolino, Bruno, Filho, Otavio Coelho, Maia, Lilia Nigro, Silva, Rodrigo, Canesin, Manoel, Rossi, Paulo Roberto Ferreira, Fortes, Jose Augusto Ribas, Cerci, Rodrigo Julio, Manenti, Euler Roberto Fernandes, Leaes, Paulo Ernesto, Silva Neto, Luis Beck, Souza, Weimar Kunz Barroso, Bacal, Fernando, Chaves, Renato, Ramires, Felix, Vidotti, Maria Helena, Barros e Silva, Pedro Gabriel Melo, Piegas, Leopoldo Soares, Todorov, Georgi, Tzekova, Maria, Goudev, Assen, Mincheva, Valentina, Vasilev, Ivaylo, Tisheva‐ Gospodinova, Snezhanka, Petrov, Ivo, Postadzhiyan, Arman, Velikov, Chavdar, Dimov, Bojidar, Constance, Christian, Phaneuf, Denis‐Carl, Mielniczuk, Lisa, Pandey, A Shekhar, Senaratne, Manohara, Zieroth, Shelley, Savard, Daniel, Stewart, Robert, Huynh, Thao, Giannetti, Nadia, Moe, Gordon, Bourgeois, Ronald, Ezekowitz, Justin, Hartleib, Michael, Sussex, Bruce, Babapulle, Mohan, Chehayeb, Raja, Gaudet, Daniel, McKelvie, Robert, Nguyen, Viviane, Roth, Sherryn, Gupta, Milan, Pesant, Yves, Rupka, Dennis, Bhargava, Rakesh, Costa‐Vitali, Atilio, Proulx, Guy, Vega, Mario, Potthoff, Sergio, Cid, Maria Cristina Schnettler, Sepulveda, Alex Mauricio Villablanca, Zanetti, Fernando Tomas Lanas, Gajardo, Victor Areli Saavedra, Kindel, Carlos Conejeros, Jofre, Christian Paolo Pincetti, Segarra, Jorge Leonardo Cobos, Venegas, Manuel Eduardo Rodriguez, Hidalgo, Mario Yanez, Jalaf, Margarita Gertrudis Vejar, Li, Weimin, Zhang, Jinguo, Fu, Xin, Zhang, Xuelian, Li, Dongye, Wang, Zhifang, Qu, Yanling, Zheng, Zhe, Tang, Huifang, Yang, Ping, Zhang, Yuhui, Zheng, Yang, Mi, Yafei, Huang, He, Bu, Peili, Chen, Guoqin, Chen, Jiyan, Han, Yajun, Li, Zhangquan, Ma, Shumei, Yang, Xuming, Yuan, Zuyi, Dong, Yugang, Li, Zhaoping, Mahemuti, Ailiman, Niu, Wentang, Yang, Zhenyu, Zhang, Yuqing, Sun, Yuemin, Wu, Weiheng, Liu, Feng, Yan, Jing, Li, Yinjun, Wang, Yi, Zhang, Shouyan, Zhou, Changyong, Cui, Hanbin, Li, Jianjun, Li, Tianfa, Han, Qinghua, Wei, Yu, Correa, Luis Eduardo Echeverria, Mendoza, Jose Luis Accini, Jattin, Fernando Manzur, Osorio, Wilder Castaño, Luengas, Carlos Alberto, Arroyo, Julian Alonso Coronel, Corredor, Miguel Alfredo Moncada, Giraldo, Clara Ines Saldarriaga, Lopez, Rodrigo Botero, Salazar, Dora Ines Molina, Triana, Miguel Urina, Lopez, Luis Horacio Atehortua, Rojas, Pastor Olaya, Pelaez, Sebastian Velez, Pareja, Monica Lopez, Bonfanti, Alberto Cadena, Polasek, Rostislav, Monhart, Zdenek, Sochor, Karel, Motovska, Zuzana, Belohlavek, Jan, Busak, Ladislav, Krupicka, Jiri, Tyl, Petr, Jerabek, Ondrej, Podpera, Ivo, Skrobakova, Janka, Peterka, Karel, Spacek, Rudolf, Cech, Vladimir, Kellnerova, Ivana, Nechvatal, Libor, Pozdisek, Zbynek, Houra, Marek, Kryza, Radim, Machova, Vilma, Cepelak, Michal, Stepek, David, Zeman, Kamil, Klimsa, Zdenek, Koleckar, Pavel, Schee, Alexandr, Spinarova, Lenka, Coufal, Zdenek, Jeppesen, Jorgen, Vraa, Soren, Wiggers, Henrik, Nyvad, Ole, Nielsen, Tonny, Kaiser‐Nielsen, Peter, Videbaek, Lars, Galinier, Michel, Lefebvre, Jean‐Marie, Tartiere, Jean‐Michel, De Geeter, Guillaume, Roubille, Francois, Ricci, Jean Etienne, Salvat, Muriel, Gueffet, Jean‐Pierre, Decoulx, Eric, Berdague, Philippe, Jondeau, Guillaume, Ovize, Michel, Groote, Pascal De, Donal, Erwan, Isnard, Richard, Sabatier, Rémi, Trochu, Jean Noel, Damy, Thibaud, Georges, Jean‐Louis, Rosamel, Yann, Picard, François, Aboyans, Victor, Laperche, Thierry, Mitrovic, Veselin, Taggeselle, Jens, Störk, Stefan, Ebelt, Henning, Genth‐Zotz, Sabine, Rassaf, Tienush, Duengen, Hans‐Dirk, Mittag, Marcus, Menck, Niels, Zeymer, Uwe, Haehling, Stephan, Boehm, Michael, Frankenstein, Lutz, Killat, Holger, Bourhaial, Hakima, Beug, Daniel, Horacek, Thomas, Pfister, Roman, Sandri, Marcus, Westenfeld, Ralf, Kadel, Christoph, Karvounis, Haralambos, Patsilinakos, Sotirios, Mantas, Ioannis, Karavidas, Apostolos, Giamouzis, Grigorios, Tsioufis, Konstantinos, Naka, Katerina, Tziakas, Dimitrios, Parissis, John, Styliadis, Ioannis, Barbetseas, Ioannis, Manolis, Athanasios, Kochiadakis, George, Herczeg, Bela, Nagy, Laszlo, Nyolczas, Noemi, Toth, Kalman, Merkely, Bela, Laszlo, Zoltan, Mark, Laszlo, Szakal, Imre, Papp, Andras, Bezzegh, Katalin, Lakatos, Ferenc, Hajko, Erik, Papp, Aniko, Forster, Tamas, Lupkovics, Geza, Mohacsi, Attila, Salamon, Csaba, Aradi, Daniel, Andreka, Peter, Szasz, Gyula, Zilahi, Zsolt, Kazinczy, Rita, Margonato, Alberto, Agostoni, Piergiuseppe, Fucili, Alessandro, Piovaccari, Giancarlo, Senni, Michele, Carluccio, Erberto, Bilato, Claudio, Frigerio, Maria, Indolfi, Ciro, Sinagra, Gianfranco, Brunetti, Natale Daniele, Perna, Gianpiero, Pini, Daniela, Volterrani, Maurizio, Leonardi, Sergio, Mortara, Andrea, Friz, Hernan Emilio Francisco Polo, Rossini, Roberta, Tocchetti, Carlo Gabriele, Vincenzi, Antonella, Cavallini, Claudio, Floresta, Agata Marina, Zaca, Valerio, Giudici, Vittorio, Villani, Giovanni Quinto, Higashino, Yorihiko, Oishi, Shogo, Wada, Atsuyuki, Fukuzawa, Shigeru, Onoue, Kenji, Koike, Akihiro, Koizumi, Tomomi, Masuda, Seigo, Mitsuo, Kazuhisa, Takahashi, Natsuki, Takenaka, Takashi, Tanabe, Jun, Watanabe, Naoki, Yoshida, Takeshi, Amano, Tetsuya, Ishikawa, Masahiro, Kida, Keisuke, Kubota, Toru, Nakamura, Kentaro, Sakamoto, Tomohiro, Shimomura, Mitsuhiro, Yuge, Masaru, Doi, Masayuki, Domae, Hiroshi, Ebato, Mio, Fujii, Kenshi, Fujiwara, Wakaya, Gohara, Seiichiro, Hata, Yoshiki, Kanda, Junji, Kitaoka, Hiroaki, Matsumoto, Takashi, Michishita, Ichiro, Miura, Shinichiro, Miyazaki, Tetsuro, Nakamura, Akihiro, Ogawa, Tomohiro, Okumura, Takahiro, Okumura, Yasuo, Sakai, Tetsuo, Sato, Yukihito, Shimizu, Wataru, Sugino, Hiroshi, Suzuki, Masahiro, Takagi, Atsutoshi, Takaishi, Hiroshi, Tanaka, Takahiro, Terasaki, Toshiro, Tsujimoto, Mitsuru, Ueda, Yasunori, Ujino, Keiji, Usui, Makoto, Yamamoto, Mitsutaka, Yoshikawa, Masaki, Ando, Kenji, Asakura, Masanori, Asano, Hiroshi, Fujii, Shigeru, Hara, Hisao, Inomata, Takayuki, Isshiki, Takaaki, Kadokami, Toshiaki, Kai, Hisashi, Kasai, Toshio, Kawamitsu, Katsunori, Kawasaki, Tomohiro, Koga, Tokushi, Komiyama, Nobuyuki, Maejima, Yasuhiro, Manita, Mamoru, Miyamoto, Nobuhide, Node, Koichi, Numaguchi, Kotaro, Sakata, Yasushi, Serikawa, Takeshi, Takama, Noriaki, Tatebe, Shunsuke, Ueno, Hideki, Hidaka, Takayuki, Hiroi, Shitoshi, Iseki, Harukazu, Ito, Hiroshi, Kajinami, Kouji, Kawakami, Hideo, Momiyama, Yukihiko, Mori, Masuki, Morita, Yukiko, Okishige, Kaoru, Sakagami, Satoru, Takeishi, Yasuchika, Terasawa, Akihiro, Utsu, Noriaki, Badariene, Jolita, Celutkiene, Jelena, Slapikas, Rimvydas, Jarasuniene, Dalia, Castillo, Armando Garcia, De los Rios Ibarra, Manuel Odin, Lopez, Gabriel Arturo Ramos, Llamas, Edmundo Alfredo Bayram, Esperon, Guillermo Antonio Llamas, Vazquez, Eduardo Salcido, Gonzalez, Ricardo Garcia, Leon, Jose Luis Arenas, Gonzalez, Salvador Leon, Mendoza, Maria Alexandra Arias, Rodriguez, Alicia Contreras, Machado, Gustavo Francisco Mendez, Salazar, Melchor Alpizar, Ruiz, Alberto Esteban Bazzoni, Flores, Ana Maria De Leon, Carrasco, Jose Alfredo Pagola, Araiza, Raul Reyes, Römer, Tjeerd, Remmen, Johannes, Van Eck, Jacob, Elvan, Arif, Smilde, Tom, Voors, Adriaan, Wal, Ruud, Schaap, Jeroen, Sluis, Aize, Linssen, Gerardus, Magro, Michael, Willems, Frank, Hal, John, Zwaan, Coenraad, Beelen, Driek, Boswijk, Dirk, Hermans, Walter, Van Kesteren, Henricus, Scott, Russell, Hart, Hamish, Lund, Marianne, Szczasny, Marcin, Blicharski, Tomasz, Kafara, Mariusz, Stankiewicz, Anna, Skonieczny, Grzegorz, Zabowka, Maciej, Kania, Grzegorz, Kopaczewski, Jerzy, Pawlowicz, Lidia, Spyra, Janusz, Wlodarczyk, Aleksander, Sciborski, Ryszard, Balsam, Pawel, Drozdz, Jaroslaw, Sobkowicz, Bozena, Konieczynska, Malgorzata, Lelonek, Malgorzata, Bednarkiewicz, Zbigniew, Trebacz, Jaroslaw, Jankowski, Piotr, Sidor, Mateusz, Berkowski, Piotr, Chmielak, Zbigniew, Lenartowska, Lucyna, Nessler, Jadwiga, Straburzynska‐Migaj, Ewa, Kalarus, Zbigniew, Kowalski, Robert, Kalecinska‐Krystkiewicz, Ewa, Gola, Zbigniew, Pijanowski, Zbigniew, Wozakowska‐Kaplon, Beata, Cymerman, Krzysztof, Rynkiewicz, Andrzej, Miekus, Pawel, Monteiro, Pedro, Sarmento, Pedro Morais, Almeida, Filipa, Duarte, Tatiana, Fonseca, Candida, Oliveira, Luis, Santos, Luis, Brito, Dulce, Stanciulescu, Gabriela, Spiridon, Marilena Renata, Militaru, Constantin, Podoleanu, Cristian Gheorghe, Zdrenghea, Dumitru, Popescu, Mircea Ioachim, Macarie, Cezar‐Eugen, Giuca, Alina, Mitu, Florin, Voicu, Olga‐Cristina, Dorobantu, Maria, Lighezan, Daniel, Stamate, Sorin, Bykov, Alexander, Kobalava, Zhanna, Zrazhevskiy, Konstantin, Semenova, Irina, Vishnevsky, Alexander, Shutemova, Elena, Tereschenko, Sergey, Shvarts, Yury, Barbarash, Olga, Lukyanov, Yury, Voevoda, Mikhail, Dovgolis, Svetlana, Dronov, Dmitry, Goloshchekin, Boris, Sitnikova, Maria, Ezhov, Marat, Tarasov, Nikolay, Kotelnikov, Mikhail, Kostenko, Viktor, Solovev, Oleg, Goncharov, Ivan, Myasnikov, Roman, Rafalskiy, Vladimir, Ryabov, Vyacheslav, Kosmacheva, Elena, Motylev, Igor, Nosov, Vladimir, Osipova, Irina, Salukhov, Vladimir, Belenkiy, Dmitriy, Bolshakova, Olga, Pimenov, Leonid, Shilkina, Nataliya, Kulibaba, Elena, Repin, Alexey, Timofeev, Alexander, Mitrokhin, Vladislav, Sherenkov, Alexander, Arbolishvili, Georgy, Antalik, Lubomir, Dzupina, Andrej, Fulop, Peter, Majercak, Ivan, Gonsorcik, Jozef, Vinanska, Daniela, Lenner, Egon, Lukacova, Jana, Margoczy, Roman, Smik, Rudolf, Stevlik, Jan, Uhliar, Rudolf, Burgess, Lesley, Badat, Aysha, Klug, Eric, Van Zyl, Louis, Abelson, Mark, Moodley, Rajendran, Tsabedze, Nqoba, Fourie, Nyda, Bonet, Luis Almenar, Prado, Jose Maria Arizon, Oliveira Soares, Manue Martinez‐Selles D, Villota, Julio Eduardo Nuñez, Leiro, Maria Generosa Crespo, Juanatey, Jose Ramon Gonzalez, Figal, Domingo Andres Pascual, Palomas, Juan Luis Bonilla, Perez, Sonia Mirabet, Jimenez, Juan Francisco Delgado, Padron, Antonio Lara, Diaz, Victor Alfonso Jimenez, Cubero, Javier Segovia, Paya, Vicente Eduardo Climent, Mayoral, Alejandro Recio, Fuente Galan, Luis, Doblas, Juan Jose Gomez, Freire, Ramon Bover, Peiro, Maria Teresa Blasco, Molina, Beatriz Diaz, Martinez, Laura Jordan, Vilchez, Francisco Gonzalez, Boman, Kurt, Karlstrom, Patric, Berglund, Stefan, Szabo, Barna, Peterson, Magnus, Wodlin, Peter, Lindholm, Carl‐Johan, Moccetti, Tiziano, Mueller, Christian, Suter, Thomas, Hullin, Roger, Meyer, Philippe, Noll, Georg, Yigit, Zerrin, Turgut, Okan Onur, Bekar, Lutfu, Sahin, Tayfun, Koldas, Zehra Lale, Celik, Ahmet, Cavusoglu, Yuksel, Demir, Mesut, Onrat, Ersel, Duzenli, Mehmet, Cosansu, Kahraman, Muderrisoglu, Ibrahim Haldun, Tuncer, Mustafa, Badak, Ozer, Nalbantgil, Sanem, Kirma, Cevat, Okuyan, Ertugrul, Guray, Umit, Prokhorov, Oleksandr, Karpenko, Oleksandr, Vakaliuk, Igor, Yagensky, Andriy, Kracz, Igor, Stanislavchuk, Mykola, Kulynych, Oleksii, Rishko, Mykola, Stets, Roman, Tseluyko, Vira, Mishchenko, Larysa, Rudenko, Leonid, Rudyk, Iurii, Alieksieieva, Liudmyla, Korzh, Oleksii, Mostovoy, Yuriy, Parkhomenko, Oleksandr, Rasputina, Lesya, Voronkov, Leonid, Lymar, Yurii, Vasilyeva, Larysa, Keeling, Philip, Barr, Craig, Wong, Kenneth, Price, Dallas, Skaria, Binoy, Clark, Andrew, Chandrasekaran, Badrinathan, Trevelyan, Jasper, Gordon, Brian, Donnelly, Patrick, Glover, Jason, Ryding, Alisdair, Weir, Robin, Lang, Chim, Roy, Debashis, Adhya, Shaumik, Clifford, Piers, Ludman, Andrew, Kalra, Paul, Lynch, Mary, Mahmood, Shahid, Al Mohammad, Abdallah, Asubiaro, Joshua, Elmahi, Einas, Muthumala, Amal, Taylor, Justin, Gupta, Dinesh, Nadar, Venkatesh, Henderson, David, Zolty, Ronald, Sauer, Andrew, Adams, Kirkwood, Chandra, Lokesh, Jaffrani, Naseem, Grewal, Gurinder, Mancini, Donna, McLean, Dalton, Vasallo, Javier, Gottlieb, Stephen, Joseph, Susan, Barua, Rajat, Gorodeski, Eiran, Mouhaffel, Asad, Chung, Eugene, Desai, Pratik, Portnay, Edward, Rama, Bhola, Shandling, Adrian, Stahl, Llyod, Heilman, Karl, Jacob, Binu, Londono, Juan, Almousalli, Omar, Ashcom, Thomas, Bauerlein, Eugene Joseph, Koo, Charles, McGrew, Frank, Rajagopalan, Navin, Robinson, Shawn, Schultz, David, Starling, Randall, Ambardekar, Amrut, Bhagwat, Ravi, Boehmer, John, Bouza, Manuel, Farris, Neil, Feitell, Scott, Ganji, Jagadeesh, Geltman, Edward, Javier, Julian, Morrow, John Andrew, Pianko, Leonard, Smart, Frank, Adler, Alexander, Brinkley, Douglas, Cardona, Jose, Coletti, Andrew, Harris, John, Hunter, Vernon, Krantz, Mori, Lang, Christopher, Lovell, Charles, Murray, David, Pillutla, Priya, Shah, Amit, Bogaev, Roberta, Dauber, Ira, Franchi, Francesco, Fremont, Richard, Hart, Terence, Hattler, Brack, Janik, Matthew, Khalife, Wissam, Malhotra, Sanjay, Mamdani, Shafiq, Nelson, William, Orgera, Marisa, Ortiz, Aurelio, Rahko, Peter, Rennyson, Stephen, Shin, Jooyoung, Tsao, Lana, Uretsky, Barry, Wahid, Faisal, Wilkett, Matt, Amanullah, Aman, Baker, Mathue, Berk, Martin, Boccalandro, Fernando, Cruz, Kimberly, Doyle, Timothy, Gianfagna, Robert, Jones, Alonzo, King, Anthony, Lepor, Norman, Martinez‐Castrillon, Melvin, Pham, Michael, Radin, Michael, Radojevic, Joseph, Ramanathan, Kodangudi, Schmalfuss, Carsten, Schnitzler, Robert, Shah, Keyur, Takata, Theodore, Bertolet, Barry, Bostick, Brian, Civitello, Andrew, Collins, John, Dib, Nabil, Fang, James, Gilmore, Richard, Gray, Wayne, Grazette, Luanda, Haddad, Tariq, Hearne, Steven, Janmohamed, Munir, Katz, Richard, Kazemi, Navid, Llerena, Sara, Lohr, Nicole, Marzouka, George, Mignone, John, Ooi, Henry, Paszczuk, Anna, Pickett, Christopher, Sampognaro, Gregory, Sawyer, Douglas, Shayani, Steven, Treasure, Charles, Vaz, Garth, Vijay, Nampalli, Williams, Celeste, Yeoman, Gary, Zhang, Lily, Aaronson, Keith, Abo‐Auda, Wael, Alharethi, Rami, Anderson, William, Ariani, Mehrdad, Banerji, Sourin, Baweja, Paramdeep, Carson, Peter, Eberly, Arthur, Elliott, James, Fernando, Ronald, Fisher, Daniel, Forman, Steven, Gabriel, George, Gogia, Harinder, Hametz, Craig, Houston, Brian, Ibrahim, Hassan, Jadbabaie, Farid, Kassiotis, Christos, Krishnamoorthy, Arun, Kwan, Michael, Lupovitch, Steven, Macias, Leonardo, Malik, Adnan, Martinez, Luis, Miyamoto, Michael, Mody, Freny, Patel, Devesh, Peart, Brenda, Pisani, Barbara, Ramos, Mark, Rivero, Mariel, Shah, Anil, Sharma, Mukesh, Sichrovsky, Tina, Simon, Marc, Singh, Deovrat, Tallet, Julio, Vaccari, Christopher, Villoch, Mario, Wheeler, Matthew, Yousuf, Kabir, Abadier, Rafik, Abdullah, Shuaib, Arora, Raveen, Aslam, Shamaila, Buynak, Robert, Chang, David, Contreras, Johanna, Halpern, Stephen, Handel, Franklin, Heitner, John, Herzog, William, Jackson, Bruce, Kao, John, Kondo, Nicholas, Koren, Michael, LeWinter, Martin, Martindale, Jeffrey, Martinez‐Arraras, Joaquin, Olsen, Stephanie, Piatek, Marek, Ranadive, Nandkishore, Randall, William, Rao, Sunder, Rawitscher, David, Rider, James, Sokos, George, Strader, J Russell, Sulemanjee, Nasir, Tahirkheli, Naeem, Trichon, Benjamin, Vanhecke, Thomas, Whellan, David, Abuannadi, Mohammad, Aggarwala, Gaurav, Ahmad, Saad, Artis, Andre, Cheirif, Jorge, Cotarlan, Vladimir, Cox, Jeremy, Eaton, Charles, Florea, Viorel, Frank, Theodore, Friedman, Keith, Ganeshram, Vedampattu, Gass, Alan, Gemignani, Anthony, Hasni, Syed, Hedgepeth, Chester, Itchhaporia, Dipti, Kaluski, Edo, Karim, Amin, Kono, Alan, Lader, Ellis, Lakshminarayanan, Batlagundu, Lewis, Neil, Malhotra, Vinay, Mayer, Nolan, Mohapatra, Robert, Nair, Nandini, O'Brien, Terrence, Pauwaa, Sunil, Rowan, Christopher, Saxena, Sanjeev, Seto, Arnold, Shah, Nishant, Singh, Pradeep, Skopicki, Hal, Stoddard, Marcus, and Sweitzer, Nancy

Subjects
R1
Abstract

Aims:\ud The safety and efficacy of the novel selective cardiac myosin activator, omecamtiv mecarbil, in patients with heart failure with reduced ejection fraction (HFrEF) is tested in the Global Approach to Lowering Adverse Cardiac outcomes Through Improving Contractility in Heart Failure (GALACTIC‐HF) trial. Here we describe the baseline characteristics of participants in GALACTIC‐HF and how these compare with other contemporary trials.\ud \ud Methods and Results:\ud Adults with established HFrEF, New York Heart Association functional class (NYHA) ≥ II, EF ≤35%, elevated natriuretic peptides and either current hospitalization for HF or history of hospitalization/ emergency department visit for HF within a year were randomized to either placebo or omecamtiv mecarbil (pharmacokinetic‐guided dosing: 25, 37.5 or 50 mg bid). 8256 patients [male (79%), non‐white (22%), mean age 65 years] were enrolled with a mean EF 27%, ischemic etiology in 54%, NYHA II 53% and III/IV 47%, and median NT‐proBNP 1971 pg/mL. HF therapies at baseline were among the most effectively employed in contemporary HF trials. GALACTIC‐HF randomized patients representative of recent HF registries and trials with substantial numbers of patients also having characteristics understudied in previous trials including more from North America (n = 1386), enrolled as inpatients (n = 2084), systolic blood pressure

Published
2020

61. Irbesartan in patients with heart failure and preserved ejection fraction

Author

Massie, Barry M., Carson, Peter E., McMurray, John J., Komajda, Michel, McKelvie, Robert, Zile, Michael R., Anderson, Susan, Donovan, Mark, Iverson, Erik, Staiger, Christoph, and Ptaszynska, Agata

Subjects
Irbesartan -- Usage, Irbesartan -- Health aspects, Heart failure -- Care and treatment, Heart failure -- Risk factors, Cardiac output -- Care and treatment
Abstract

A study was carried out to assess the benefits of irbesartan in patients with a left ventricular ejection fraction following heart failure. Results showed that no significant benefits were noticed following therapy with irbesartan.

Published
2008

62. Myocardial Infarction in Heart Failure With Preserved Ejection Fraction:Pooled Analysis of 3 Clinical Trials

Author

Cunningham, Jonathan W., Vaduganathan, Muthiah, Claggett, Brian L., John, Jenine E., Desai, Akshay S., Lewis, Eldrin F., Zile, Michael R., Carson, Peter, Jhund, Pardeep S., Kober, Lars, Pitt, Bertram, Shah, Sanjiv J., Swedberg, Karl, Anand, Inder S., Yusuf, Salim, McMurray, John J.V., Pfeffer, Marc A., and Solomon, Scott D.

Subjects
heart failure with preserved ejection fraction, myocardial infarction, clinical outcomes
Abstract

Objectives: The authors investigated the relationship between past or incident myocardial infarction (MI) and cardiovascular (CV) events in heart failure with preserved ejection fraction (HFpEF). Background: MI and HFpEF share some common risk factors. The prognostic significance of MI in patients with HFpEF is uncertain. Methods: The authors pooled data from 3 trials—CHARM Preserved (Candesartan Cilexietil in Heart Failure Assessment of Reduction in Mortality and Morbidity), I-Preserve (Irbesartan in Heart Failure With Preserved Systolic Function), and the Americas region of TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) (N = 8,916)—and examined whether MI before or following enrollment independently predicted CV death and heart failure (HF) hospitalization. Results: At baseline, 2,668 patients (30%) had history of MI. Prior MI was independently associated with greater risk of CV death (4.7 vs. 3.5 events/100 patient-years [py], adjusted hazard ratio [HR]: 1.42 [95% confidence interval (CI): 1.23 to 1.64]; p < 0.001). Excess sudden death drove this difference (1.9 vs. 1.2 events/100 py, adjusted HR: 1.55 [95% CI: 1.23 to 1.97]; p < 0.001). There was no difference in HF hospitalization (5.9 vs. 5.5 events/100 py, adjusted HR: 1.05, 95% CI: 0.92 to 1.19) or HF death by prior MI. During follow-up, MI occurred in 336 patients (3.8%). Risk of CV death increased 31-fold in the first 30 days after first post-enrollment MI, and remained 58% higher beyond 1 year after MI. Risk of first or recurrent HF hospitalization increased 2.4-fold after MI. Conclusions: Prior MI in HFpEF is associated with greater CV and sudden death but similar risk of HF outcomes. Patients with HFpEF who experience MI are at high risk of subsequent CV death and HF hospitalization. These data highlight the importance of primary and secondary prevention of MI in patients with HFpEF. (Candesartan Cilexietil in Heart Failure Assessment of Reduction in Mortality and Morbidity [CHARM Preserved]; NCT00634712; Irbesartan in Heart Failure With Preserved Systolic Function [I-Preserve]; NCT00095238; and Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist [TOPCAT]; NCT00094302)

Published
2020

63. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

Author

Packer, Milton Anker, Stefan D. Butler, Javed Filippatos, Gerasimos Pocock, Stuart J. Carson, Peter Januzzi, James and Verma, Subodh Tsutsui, Hiroyuki Brueckmann, Martina Jamal, Waheed Kimura, Karen Schnee, Janet Zeller, Cordula and Cotton, Daniel Bocchi, Edimar Boehm, Michael Choi, Dong-Ju and Chopra, Vijay Chuquiure, Eduardo Giannetti, Nadia and Janssens, Stefan Zhang, Jian Juanatey, Jose R. Gonzalez and Kaul, Sanjay Brunner-La Rocca, Hans-Peter Merkely, Bela and Nicholls, Stephen J. Perrone, Sergio Pina, Ileana and Ponikowski, Piotr Sattar, Naveed Senni, Michele Seronde, Marie-France Spinar, Jindrich Squire, Iain Taddei, Stefano and Wanner, Christoph Zannad, Faiez EMPEROR-REDUCED Trial Investigat

Abstract

BACKGROUND Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce the risk of hospitalization for heart failure in patients regardless of the presence or absence of diabetes. More evidence is needed regarding the effects of these drugs in patients across the broad spectrum of heart failure, including those with a markedly reduced ejection fraction. METHODS In this double-blind trial, we randomly assigned 3730 patients with class II, III, or IV heart failure and an ejection fraction of 40% or less to receive empagliflozin (10 mg once daily) or placebo, in addition to recommended therapy. The primary outcome was a composite of cardiovascular death or hospitalization for worsening heart failure. RESULTS During a median of 16 months, a primary outcome event occurred in 361 of 1863 patients (19.4%) in the empagliflozin group and in 462 of 1867 patients (24.7%) in the placebo group (hazard ratio for cardiovascular death or hospitalization for heart failure, 0.75; 95% confidence interval [CI], 0.65 to 0.86; P

Published
2020

64. Heart Failure Endpoints in Cardiovascular Outcome Trials of SGLT2 inhibitors in Patients with Type 2 Diabetes: A Critical Evaluation of Clinical and Regulatory Issues

Author

Butler, Javed, Packer, Milton, Greene, Stephen J., Fiuzat, Mona, Anker, Stefan D., Anstrom, Kevin J., Carson, Peter E., Cooper, Lauren B., Fonarow, Gregg C., Hernandez, Adrian F., Januzzi, James L., Jessup, Mariell, Kalyani, Rita R., Kaul, Sanjay, Kosiborod, Mikhail, Lindenfeld, JoAnn, McGuire, Darren K., Sabatine, Marc S., Solomon, Scott D., Teerlink, John R., Vaduganathan, Muthiah, Yancy, Clyde W., Stockbridge, Norman, and O’Connor, Christopher M.

Subjects
Heart Failure, Research Report, Clinical Trials as Topic, Treatment Outcome, Diabetes Mellitus, Type 2, Sodium-Glucose Transporter 2, Cardiovascular Diseases, Endpoint Determination, Humans, Sodium-Glucose Transporter 2 Inhibitors, Article
Abstract

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Published
2019

65. Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus: A Critical Evaluation of Clinical and Regulatory Issues

Author

Butler, Javed, Packer, Milton, Greene, Stephen J, Fiuzat, Mona, Anker, Stefan D, Anstrom, Kevin J, Carson, Peter E, Cooper, Lauren B, Fonarow, Gregg C, Hernandez, Adrian F, Januzzi, James L, Jessup, Mariell, Kalyani, Rita R, Kaul, Sanjay, Kosiborod, Mikhail, Lindenfeld, JoAnn, McGuire, Darren K, Sabatine, Marc S, Solomon, Scott D, Teerlink, John R, Vaduganathan, Muthiah, Yancy, Clyde W, Stockbridge, Norman, and O'Connor, Christopher M

Subjects
Research Report, Endpoint Determination, Clinical Trials and Supportive Activities, Clinical Sciences, heart failure, Cardiorespiratory Medicine and Haematology, Cardiovascular, Sodium-Glucose Transporter 2, Clinical Research, Diabetes Mellitus, Humans, Sodium-Glucose Transporter 2 Inhibitors, Heart Disease - Coronary Heart Disease, Clinical Trials as Topic, Diabetes, biomarkers, Evaluation of treatments and therapeutic interventions, clinical trial, Treatment Outcome, Heart Disease, type 2, Cardiovascular System & Hematology, Cardiovascular Diseases, 5.1 Pharmaceuticals, 6.1 Pharmaceuticals, Public Health and Health Services, Development of treatments and therapeutic interventions
Abstract

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Published
2019

67. Low-dose oral enoximone enhances the ability to wean patients with ultra-advanced heart failure from intravenous inotropic support: Results of the oral enoximone in intravenous inotrope-dependent subjects trial

Author

Feldman, Arthur M., Oren, Ron M., Abraham, William T., Boehmer, John P., Carson, Peter E., Eichhorn, Eric, Gilbert, Edward M., Kao, Andrew, Leier, Carl V., Lowes, Brian D., Mathier, Michael A., McGrew, Frank A., Metra, Marco, Zisman, Lawrence S., Shakar, Simon F., Krueger, Steven K., Robertson, Alastair D., White, Bill G., Gerber, Michael J., Wold, Gwyn E., and Bristow, Michael R.

Published
2007
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68. Developing and validating models to predict sudden death and pump failure death in patients with heart failure and preserved ejection fraction

Author

Shen, Li, primary, Jhund, Pardeep S., additional, Anand, Inder S., additional, Carson, Peter E., additional, Desai, Akshay S., additional, Granger, Christopher B., additional, Køber, Lars, additional, Komajda, Michel, additional, McKelvie, Robert S., additional, Pfeffer, Marc A., additional, Solomon, Scott D., additional, Swedberg, Karl, additional, Zile, Michael R., additional, and McMurray, John J. V., additional

Published
2020
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69. Standardized definitions for evaluation of heart failure therapies: scientific expert panel from the Heart Failure Collaboratory and Academic Research Consortium

Author

Abraham, William T., primary, Psotka, Mitchell A., additional, Fiuzat, Mona, additional, Filippatos, Gerasimos, additional, Lindenfeld, JoAnn, additional, Mehran, Roxana, additional, Ambardekar, Amrut V., additional, Carson, Peter E., additional, Jacob, Richard, additional, Januzzi, James L., additional, Konstam, Marvin A., additional, Krucoff, Mitchell W., additional, Lewis, Eldrin F., additional, Piccini, Jonathan P., additional, Solomon, Scott D., additional, Stockbridge, Norman, additional, Teerlink, John R., additional, Unger, Ellis F., additional, Zeitler, Emily P., additional, Anker, Stefan D., additional, and O'Connor, Christopher M., additional

Published
2020
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70. Valsartan reduces the incidence of atrial fibrillation in patients with heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)

Author

Maggioni, Aldo P., Latini, Roberto, Carson, Peter E., Singh, Steven N., Barlera, Simona, Glazer, Robert, Masson, Serge, Cere, Elisabetta, Tognoni, Gianni, and Cohn, Jay N.

Subjects
Renin-angiotensin system -- Drug therapy, Heart failure -- Drug therapy, Atrial fibrillation -- Patient outcomes, ACE inhibitors -- Drug therapy, Health
Published
2005

71. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure

Author

Taylor, Anne L., Ferdinand, Keith, Taylor, Malcolm, Ziesche, Susan, Adams, Kirkwood, Yancy, Clyde, Sabolinski, Michael, Carson, Peter, Worcel, Manuel, Cohn, Jay N., and D'Agostino, Ralph, Jr.

Subjects
Heart failure -- Diagnosis, Hydralazine -- Research, Isosorbide dinitrate -- Research
Abstract

A study examining whether a fixed dose of both isosorbide dinitrate and hydralazine provides additional benefit in African-Americans with advanced heart failure is discussed. It is found that addition of a fixed dose of both isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among African-American patients with advanced heart failure.

Published
2004

74. Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure

Author

Packer, Milton, primary, Anker, Stefan D., additional, Butler, Javed, additional, Filippatos, Gerasimos, additional, Pocock, Stuart J., additional, Carson, Peter, additional, Januzzi, James, additional, Verma, Subodh, additional, Tsutsui, Hiroyuki, additional, Brueckmann, Martina, additional, Jamal, Waheed, additional, Kimura, Karen, additional, Schnee, Janet, additional, Zeller, Cordula, additional, Cotton, Daniel, additional, Bocchi, Edimar, additional, Böhm, Michael, additional, Choi, Dong-Ju, additional, Chopra, Vijay, additional, Chuquiure, Eduardo, additional, Giannetti, Nadia, additional, Janssens, Stefan, additional, Zhang, Jian, additional, Gonzalez Juanatey, Jose R., additional, Kaul, Sanjay, additional, Brunner-La Rocca, Hans-Peter, additional, Merkely, Bela, additional, Nicholls, Stephen J., additional, Perrone, Sergio, additional, Pina, Ileana, additional, Ponikowski, Piotr, additional, Sattar, Naveed, additional, Senni, Michele, additional, Seronde, Marie-France, additional, Spinar, Jindrich, additional, Squire, Iain, additional, Taddei, Stefano, additional, Wanner, Christoph, additional, and Zannad, Faiez, additional

Published
2020
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79. Racial differences in the outcome of left ventricular dysfunction

Author

Dries, Daniel L., Exner, Derek V., Gersh, Bernard J., Cooper, Howard A., Carson, Peter E., and Domanski, Michael J.

Subjects
Congestive heart failure -- Demographic aspects, African Americans -- Health aspects, Health and race -- Analysis
Abstract

Blacks with congestive heart failure seem to have a higher risk of death than whites even after adjusting for other factors. This was the conclusion of researchers who analyzed data from the Studies of Left Ventricular Dysfunction (SOLVD) trial. Black patients had higher mortality rates after adjusting for age, coexisting diseases, cause of and severity of heart failure and the use of certain drugs. Blacks even had a higher risk of death from all causes.

Published
1999

84. Evaluation of the effect of sodium–glucose co‐transporter 2 inhibition with empagliflozin on morbidity and mortality of patients with chronic heart failure and a reduced ejection fraction: rationale for and design of the EMPEROR‐Reduced trial

Author

Packer, Milton, Butler, Javed, Filippatos, Gerasimos S., Jamal, Waheed, Salsali, Afshin, Schnee, Janet, Kimura, Karen, Zeller, Cordula, George, Jyothis, Brueckmann, Martina, Anker, Stefan D., Zannad, Faiez, Filippatos, Gerasimos, Perrone, Sergio, Nicholls, Stephen, Janssens, Stefan, Bocchi, Edmar, Giannetti, Nadia, Verma, Subodh, Jian, Zhang, Spinar, Jindrich, Seronde, Marie‐France, Böhm, Michael, Merkely, Bela, Chopra, Vijay, Senni, Michele, Taddei, Stefano, Tsutsui, Hiroyuki, Choi, Dong‐Ju, Chuquiure, Eduardo, La Rocca, Hans Pieter Brunner, Ponikowski, Piotr, Juanatey, Jose Ramon Gonzalez, Squire, Iain, Januzzi, James, Pina, Ileana, Pocock, Stuart J., Carson, Peter, Doehner, Wolfram, Miller, Alan, Haas, Markus, Pehrson, Steen, Komajda, Michel, Anand, Inder, Teerlink, John, Rabinstein, Alejandro, Steiner, Thorsten, Kamel, Hooman, Tsivgoulis, Georgios, Lewis, James, Freston, James, Kaplowitz, Neil, Mann, Johannes, Petrie, Mark, Bernstein, Richard, Cheung, Alfred, Green, Jennifer, Kaul, Sanjay, Ping, Carolyn Lam Su, Lip, Gregory, Marx, Nikolaus, McCullough, Peter, Mehta, Cyrus, Rosenstock, Julio, Sattar, Naveed, Scirica, Benjamin, Wanner, Christoph, Welty, Francine K., Parhofer, Klaus G., Clayton, Tim, Pedersen, Terje R., Lees, Kennedy R., Konstam, Marvin A., Greenberg, Barry, and Palmer, Mike

Abstract

Drugs that inhibit the sodium–glucose co‐transporter 2 (SGLT2) have been shown to reduce the risk of hospitalizations for heart failure in patients with type 2 diabetes. In populations that largely did not have heart failure at the time of enrolment, empagliflozin, canagliflozin and dapagliflozin decreased the risk of serious new‐onset heart failure events by ≈30%. In addition, in the EMPA‐REG OUTCOME trial, empagliflozin reduced the risk of both pump failure and sudden deaths, the two most common modes of death among patients with heart failure. In none of the three trials could the benefits of SGLT2 inhibitors on heart failure be explained by the actions of these drugs as diuretics or anti‐hyperglycaemic agents. These observations raise the possibility that SGLT2 inhibitors could reduce morbidity and mortality in patients with established heart failure, including those without diabetes. The EMPEROR‐Reduced trial is enrolling ≈3600 patients with heart failure and a reduced left ventricular ejection fraction (≤ 40%), half of whom are expected not to have diabetes. Patients are being randomized to placebo or empagliflozin 10 mg daily, which is added to all appropriate treatment with inhibitors of the renin–angiotensin system and neprilysin, beta‐blockers and mineralocorticoid receptor antagonists. The primary endpoint is the time‐to‐first event analysis of the combined risk of cardiovascular death and hospitalization for heart failure, but the trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death, all‐cause mortality, and recurrent hospitalization events. By adjusting eligibility based on natriuretic peptide levels to the baseline ejection fraction, the trial will preferentially enrol high‐risk patients. A large proportion of the participants is expected to have an ejection fraction

Published
2019

85. Evaluation of the effects of sodium–glucose co‐transporter 2 inhibition with empagliflozin on morbidity and mortality in patients with chronic heart failure and a preserved ejection fraction: rationale for and design of the EMPEROR‐Preserved Trial

Author

Anker, Stefan D., Butler, Javed, Filippatos, Gerasimos S., Jamal, Waheed, Salsali, Afshin, Schnee, Janet, Kimura, Karen, Zeller, Cordula, George, Jyothis, Brueckmann, Martina, Zannad, Faiez, Packer, Milton, Perrone, Sergio, Nicholls, Stephen, Janssens, Stefan, Bocchi, Edmar, Giannetti, Nadia, Verma, Subodh, Jian, Zhang, Gomez Mesa, Juan Esteban, Spinar, Jindrich, Böhm, Michael, Merkely, Bela, Chopra, Vijay, Senni, Michele, Taddi, Stefano, Tsutsui, Hiroyuki, Chuquiure, Eduardo, La Rocca, Hans Pieter Brunner, Ponikowski, Piotr, Vinereanu, Dragos, Sim, David, Choi, Dong‐Ju, Juanatey, Jose Ramon Gonzalez, Squire, Iain, Januzzi, James, Pina, Ileana, Pocock, Stuart J., Carson, Peter, Doehner, Wolfram, Miller, Alan, Haas, Markus, Pehrson, Steen, Komajda, Michel, Anand, Inder, Teerlink, John, Rabinstein, Alejandro, Steiner, Thorsten, Kamel, Hooman, Tsivgoulis, Georgios, Lewis, James, Freston, James, Kaplowitz, Neil, Mann, Johannes, Petrie, Mark, Bernstein, Richard, Cheung, Alfred, Green, Jennifer, Kaul, Sanjay, Ping, Carolyn Lam Su, Lip, Gregory, Marx, Nikolaus, McCullough, Peter, Mehta, Cyrus, Rosenstock, Julio, Sattar, Naveed, Scirica, Benjamin, Wanner, Christoph, Welty, Francine K., Parhofer, Klaus G., Clayton, Tim, Pedersen, Terje R., Lees, Kennedy R., Konstam, Marvin A., Greenberg, Barry, and Palmer, Mike

Abstract

Background:\ud The principal biological processes that characterize heart failure with a preserved ejection fraction (HFpEF) are systemic inflammation, epicardial adipose tissue accumulation, coronary microcirculatory rarefaction, myocardial fibrosis and vascular stiffness; the resulting impairment of left ventricular and aortic distensibility (especially when accompanied by impaired glomerular function and sodium retention) causes increases in cardiac filling pressures and exertional dyspnoea despite the relative preservation of left ventricular ejection fraction. Independently of their actions on blood glucose, sodium–glucose co‐transporter 2 (SGLT2) inhibitors exert a broad range of biological effects (including actions to inhibit cardiac inflammation and fibrosis, antagonize sodium retention and improve glomerular function) that can ameliorate the pathophysiological derangements in HFpEF. Such SGLT2 inhibitors exert favourable effects in experimental models of HFpEF and have been found in large‐scale trials to reduce the risk for serious heart failure events in patients with type 2 diabetes, many of whom were retrospectively identified as having HFpEF.\ud \ud Study design:\ud The EMPEROR‐Preserved Trial is enrolling ≈5750 patients with HFpEF (ejection fraction >40%), with and without type 2 diabetes, who are randomized to receive placebo or empagliflozin 10 mg/day, which is added to all appropriate treatments for HFpEF and co‐morbidities.\ud \ud Study aims:\ud The primary endpoint is the time‐to‐first‐event analysis of the combined risk for cardiovascular death or hospitalization for heart failure. The trial will also evaluate the effects of empagliflozin on renal function, cardiovascular death,\ud \ud all‐cause mortality and recurrent hospitalization events, and will assess a wide range of biomarkers that reflect important pathophysiological mechanisms that may drive the evolution of HFpEF. The EMPEROR‐Preserved Trial is well positioned to determine if empagliflozin can have a meaningful impact on the course of HFpEF, a disorder for which there are currently few therapeutic options.

Published
2019

86. Rationale and design of the EMPERIAL‐Preserved and EMPERIAL‐Reduced trials of empagliflozin in patients with chronic heart failure

Author

Abraham, William T., Ponikowski, Piotr, Brueckmann, Martina, Zeller, Cordula, Macesic, Hemani, Peil, Barbara, Brun, Michèle, Ustyugova, Anastasia, Jamal, Waheed, Salsali, Afshin, Lindenfeld, JoAnn, Anker, Stefan D., Abraham, William, Anker, Stefan, Welty, Francine, Clayton, Tim, Greenberg, Barry, Konstam, Marvin, Lees, Kennedy, Palmer, Mike, Parhofer, Klaus, Pedersen, Terje, Carson, Peter, Freston, James, Kaplowitz, Neil, Lewis, James, Mann, Johannes, Petrie, John, Agostoni, Piergiuseppe, Butler, Javed, Desai, Akshay, Filippatos, Gerasimos, Howlett, Jonathan, Wranicz, Jerzy, Mas, Josep Redón, Cardoso, José Silva, and Störk, Stefan

Subjects
Adult, Male, medicine.medical_specialty, Trial Design, Empagliflozin, Type 2 diabetes, 030204 cardiovascular system & hematology, Placebo, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Glucosides, Quality of life, Internal medicine, Exercise capacity, medicine, Clinical endpoint, Humans, Patient Reported Outcome Measures, Benzhydryl Compounds, Sodium-Glucose Transporter 2 Inhibitors, Randomized Controlled Trials as Topic, Heart Failure, Exercise Tolerance, Study Design, Ejection fraction, business.industry, Heart failure, Sodium-glucose co-transporter 2 inhibitor, Stroke Volume, Physical Functional Performance, medicine.disease, 3. Good health, Sodium–glucose co‐transporter 2 inhibitor, Clinical trial, Diabetes Mellitus, Type 2, Quality of Life, Cardiology, Female, Drug Monitoring, Cardiology and Cardiovascular Medicine, business
Abstract

AIMS: Heart failure (HF) is associated with considerable symptom burden and impairment in physical functioning and quality of life. The sodium-glucose co-transporter 2 inhibitor empagliflozin reduced the risk of HF hospitalisation and cardiovascular death in patients with type 2 diabetes and established cardiovascular disease in the EMPA-REG OUTCOME trial, and could potentially improve congestion symptoms and exercise capacity in patients with HF. We describe the designs of the EMPERIAL-Preserved and EMPERIAL-Reduced trials of empagliflozin in patients with chronic stable HF, with or without type 2 diabetes. METHODS: EMPERIAL-Preserved and EMPERIAL-Reduced are randomised, placebo-controlled trials designed to investigate the effects of empagliflozin on exercise capacity and patient-reported outcomes in patients with chronic stable HF with preserved ejection fraction [HFpEF; left ventricular ejection fraction (LVEF) > 40%] and HF with reduced ejection fraction (HFrEF; LVEF ≤ 40%), respectively. In each trial, approximately 300 patients will be randomised 1:1 to receive empagliflozin 10 mg or placebo once daily for 12 weeks. In both trials, the primary endpoint is the change from baseline in 6-min walk test distance at week 12. Key secondary endpoints are the change from baseline in Kansas City Cardiomyopathy Questionnaire total symptom score and change from baseline in dyspnoea score of the Chronic Heart Failure Questionnaire at week 12. CONCLUSION: The EMPERIAL-Preserved and EMPERIAL-Reduced trials will determine the effects of empagliflozin on exercise capacity and patient-reported outcomes in patients with HFpEF and HFrEF, respectively, and provide insight into the potential of empagliflozin in the treatment of patients with HF. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03448406 (EMPERIAL-Preserved), NCT03448419 (EMPERIAL-Reduced). peerReviewed

Published
2019

88. Effect of amlodipine on morbidity and mortality in severe chronic heart failure

Author

Packer, Milton, O'Connor, Christopher M., Ghali, Jalal K., Pressler, Milton L., Carson, Peter E., Belkin, Robert N., Miller, Alan B., Neuberg, Gerald W., Frid, David, Wertheimer, John H., Cropp, Anne B., and DeMets, David L.

Subjects
Heart failure -- Drug therapy, Calcium channel blockers -- Evaluation
Abstract

The calcium channel blocker amlodipine appears to be safe when used in patients with chronic heart failure. Researchers randomly assigned 1,135 patients in heart failure to take amlodipine or a placebo. Amlodipine reduced the risk of fatal and nonfatal cardiovascular events and also reduced the death rate. This difference was seen most dramatically in patients whose heart failure was caused by dilated cardiomyopathy. Amlodipine reduced the risk of death by 46% in this group. However, it appeared to have no effect in those with coronary heart disease.

Published
1996

89. Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction

Author

Shen, Li, Rørth, Rasmus, Cosmi, Deborah, Kristensen, Søren Lund, Petrie, Mark C, Cosmi, Franco, Latini, Roberto, Køber, Lars, Anand, Inder S, Carson, Peter E, Granger, Christopher B, Komajda, Michel, McKelvie, Robert S, Solomon, Scott D, Staszewsky, Lidia, Swedberg, Karl, Huynh, Thao, Zile, Michael R, Jhund, Pardeep S, McMurray, John J V, Shen, Li, Rørth, Rasmus, Cosmi, Deborah, Kristensen, Søren Lund, Petrie, Mark C, Cosmi, Franco, Latini, Roberto, Køber, Lars, Anand, Inder S, Carson, Peter E, Granger, Christopher B, Komajda, Michel, McKelvie, Robert S, Solomon, Scott D, Staszewsky, Lidia, Swedberg, Karl, Huynh, Thao, Zile, Michael R, Jhund, Pardeep S, and McMurray, John J V

Abstract

AIMS: Insulin causes sodium retention and hypoglycaemia and its use is associated with worse outcomes in heart failure (HF) with reduced ejection fraction. We have investigated whether this is also the case in HF with preserved ejection fraction (HFpEF).METHODS AND RESULTS: We examined the association between diabetes/diabetes treatments and the risk of the primary composite of cardiovascular death or HF hospitalization, as well as other outcomes in adjusted analyses in CHARM-Preserved (left ventricular ejection fraction ≥ 45%), I-Preserve and TOPCAT (Americas) pooled. Of 8466 patients, 2653 (31%) had diabetes, including 979 (37%) receiving insulin. Patients receiving insulin were younger, had a higher body mass index, prevalence of ischaemic aetiology, N-terminal pro-B-type natriuretic peptide and use of diuretics, worse New York Heart Association class and signs and symptoms, and worse quality of life and renal function, compared to patients with diabetes not on insulin. Among the 1398 patients with echocardiographic data, insulin use was associated with higher left ventricular end-diastolic pressure and more diastolic dysfunction than in other participants. The primary outcome occurred at a rate of 6.3 per 100 patient-years in patients without diabetes, and 10.2 and 17.1 per 100 patient-years in diabetes patients without and with insulin use, respectively [fully adjusted hazard ratio (aHR) insulin-treated diabetes vs. other diabetes: 1.41, 95% confidence interval (CI) 1.23-1.63, P < 0.001]. The adjusted HR is 1.67 (95% CI 1.20-2.32, p = 0.002) for sudden death (insulin-treated diabetes vs. other diabetes).CONCLUSIONS: Insulin use is associated with poor outcomes in HFpEF. Although we cannot conclude a causal association, the safety of insulin and alternative glucose-lowering treatments in HF needs to be evaluated in clinical trials.

Published
2019

91. Effects of vesnarinone on morbidity and mortality of patients with heart failure

Author

Feldman, Arthur M., Bristow, Michael R., Parmley, William W., Carson, Peter E., Pepine, Carl J., Gilbert, Edward M., Strobeck, John E., Hendrix, Grady H., Powers, Eric R., Bain, Raymond P., and White, B.G.

Subjects
Cardiotonic agents -- Health aspects, Heart failure -- Drug therapy
Abstract

A low dose of vesnarinone may be an effective and safe treatment for congestive heart failure. Treatment with a higher dose may cause life-threatening complications. Among 477 patients with congestive heart failure, 239 were treated with 60 milligrams (mg) of vesnarinone per day and 238 were treated with a placebo, or inactive substance. Twenty-six patients treated with vesnarinone had progressively worse heart failure or died, compared with 50 patients who received a placebo. Patients in the vesnarinone group experienced a significant improvement in their quality of life over a 12-week period. Of 87 patients with congestive heart failure who were treated with 120 mg of vesnarinone per day, 16 died and half of these deaths occurred within the first six weeks of treatment. Treatment with 120 mg of vesnarinone per day was discontinued because it was too dangerous.

Published
1993

93. Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: Results from efficacy of vasopressin antagonism in heart failure outcome study with tolvaptan (EVEREST) program

Author

OʼConnor, Christopher M., Miller, Alan B., Blair, John E.A., Konstam, Marvin A., Wedge, Patricia, Bahit, Maria C., Carson, Peter, Haass, Markus, Hauptman, Paul J., Metra, Marco, Oren, Ron M., Patten, Richard, Piña, Ileana, Roth, Sherryn, Sackner-Bernstein, Jonathan D., Traver, Brian, Cook, Thomas, and Gheorghiade, Mihai

Published
2010

94. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure

Author

Cohn, Jay N., Johnson, Gary, Ziesche, Susan, Cobb, Frederick, Francis, Gary, Tristani, Felix, Smith, Raphael, Dunkman, W. Bruce, Loeb, Henry, Wong, Maylene, Bhat, Geetha, Goldman, Steven, Fletcher, Ross D., Doherty, James, Hughes, C. Vincent, Carson, Peter, Cintron, Guillermo, Shabetai, Ralph, and Haakenson, Clair

Subjects
Isosorbide dinitrate -- Dosage and administration, Enalapril -- Dosage and administration, Congestive heart failure, Vasodilators -- Dosage and administration, Hydralazine -- Dosage and administration
Abstract

Chronic heart failure affects about two million people, and reduces both the quality and length of life. It is characterized by abnormal function of the left ventricle, and results in diminished pumping action of the heart. Recent studies have indicated that vasodilators, drugs that dilate or widen blood vessels, may reduce mortality and improve heart functioning in patients with this disease. Hydralazine-isosorbide dinitrate, a vasodilator, has been shown to be effective in treating mild-to-moderate congestive heart failure. Enalapril, a relatively new vasodilator, has been reported to be relieve the symptoms of severe congestive heart failure. However, its effect in treating mild-to-moderate cases is unknown. To determine which drug is more effective in reducing mortality and treating chronic congestive heart failure, 804 male patients with mild-to-moderate congestive heart failure received either enalapril (403 patients) or hydralazine-isosorbide dinitrate (401 patients). During follow-up, which ranged from 6 months to 5.7 years, 285 patients died; 132 from the enalapril group and 153 from the hydralazine-isosorbide dinitrate group. After two years of therapy, mortality was significantly lower in the enalapril group due largely to the decreased incidence of sudden death among these patients. Blood pressure was significantly lower for the first 13 weeks and heart rate was significantly lower for the first year in the enalapril group. Ejection fractions (the percentage of blood pumped from the left ventricle at the end of a heartbeat) were significantly increased with both drugs, but were significantly greater in the hydralazine-isosorbide dinitrate group for the first 13 weeks. This group also experienced significantly increased oxygen consumption during exercise testing in the first year of therapy. The number of hospitalizations was similar for both groups. These results confirm previous findings previous regarding the beneficial effects of vasodilators on reducing mortality in patients with congestive heart failure. Enalapril was more effective in reducing mortality, while hydralazine-isosorbide dinitrate had more favorable effects on some physiologic variables. A combination of the two drugs might provide even better results. (Consumer Summary produced by Reliance Medical Information, Inc.)

Published
1991

96. Insulin treatment and clinical outcomes in patients with diabetes and heart failure with preserved ejection fraction

Author

Shen, Li, primary, Rørth, Rasmus, additional, Cosmi, Deborah, additional, Kristensen, Søren Lund, additional, Petrie, Mark C., additional, Cosmi, Franco, additional, Latini, Roberto, additional, Køber, Lars, additional, Anand, Inder S., additional, Carson, Peter E., additional, Granger, Christopher B., additional, Komajda, Michel, additional, McKelvie, Robert S., additional, Solomon, Scott D., additional, Staszewsky, Lidia, additional, Swedberg, Karl, additional, Huynh, Thao, additional, Zile, Michael R., additional, Jhund, Pardeep S., additional, and McMurray, John J.V., additional

Published
2019
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97. OPTIMAL MEDICAL THERAPY USE AND LONG-TERM OUTCOMES IN CABG-ELIGIBLE HEART FAILURE PATIENTS: INSIGHTS FROM THE STICH TRIAL

Author

Farsky, Pedro Silvio, primary, White, Jennifer, additional, Sueta, Carla, additional, Dabrowski, Rafal, additional, Djokovic, Ljubomir, additional, Drazner, Mark, additional, Haddad, Haissam, additional, Ali, Imtiaz, additional, Keltai, Matyas, additional, Naik, Ajay, additional, Sopko, George, additional, Golba, Krzysztof, additional, Andersson, Bert, additional, Carson, Peter, additional, Kukulski, Tomasz, additional, Al-Khalidi, Hussein, additional, Rouleau, Jean, additional, and Velazquez, Eric, additional

Published
2019
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99. On the waterfront

Author

Robinson, Victor, Fawcett, Peter, Orlowski, Rafal, Carson, Peter, and Dawson, Susan

Subjects
Belfast, Northern Ireland -- Buildings and facilities, Music-halls -- Design and construction, Architecture and design industries, Business, Business, international
Abstract

Architectural firm Robinson and McIlwaine took great care to achieve an appropriate balance between solid masonry and glass in its design for the Waterfront Hall in Belfast, Northern Ireland. This ensured that the right level of transparency was achieved from inside and out. The building is designed as a symphony hall, but must also be used for many other purposes, and is therefore extremely flexible. It features a double-skin concrete roof, as it is located beneath the flight path to Belfast city airport.

Published
1997

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