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