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3. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Author

Auer, Johann, Hubauer, Martin, Pandzic, Sead, Preishuber, Eva, Primus-Grabscheit, Carina, Reitgruber, Dietmar, Schmalzer, Florian, Adlbrecht, Christopher, Schober, Andreas, Hajos, Johannes, Keil, Christoph, Schratter, Alexandra, Frick, Matthias, Benda, Magdalena Anna, Mächler, Maximilian, Mutschlechner, Beatrix, Saely, Christoph, Sprenger, Lukas, Lichtenauer, Michael, Eber, Miriam, Hoppe, Uta, Kolbitsch, Tobias, Jirak, Peter Michael, Mirna, Moritz, Schönbauer, Robert, Bergler-Klein, Jutta, Hengstenberg, Christian, Stojkovic, Stefan, Scherr, Daniel, Manninger-Wünscher, Martin, Rohrer, Ursula, Stühlinger, Markus, Schgoer, Wilfried, Schwarzl, Jana, Pürerfellner, Helmut, Derndorfer, Michael, Ebner, Christian, Eder, Veronika, Kollias, Georgios, Sturmberger, Thomas, Sieghartsleitner, Stefan, Vijgen, Johan, Koopman, Peter, Dujardin, Karl, Anné, Wim, De Ceuninck, Michel, Tavernier, Rene, Duytschaever, Mattias, Knecht, Sébastien, Missault, Luc, Vandekerckhove, Yves, Rossenbacker, Tom, Ector, Bavo, Charlier, Filip, Debruyne, Philippe, Dewilde, Willem, Janssens, Luc, Roosen, John, Vankelecom, Bart, Heidbuchel, Hein, Delesie, Michiel, Vervoort, Gert, Rombouts, Hans, Vanassche, Thomas, Engelen, Matthias, Verhamme, Peter, Willems, Rik, Constance, Christian, Pranno, Nicolas, Cox, Jafna, Bata, Iqbal, Macle, Laurent, Aguilar, Martin, Tourigny, Julia Cadrin, Dubuc, Marc, Dyrda, Katia, Guerra, Peter, Khairy, Paul, Mondésert, Blandine, Rivard, Léna, Roy, Denis, Tadros, Rafik, Talajic, Mario, Thibault, Bernard, Nault, Isabelle, Blier, Louis, Champagne, Jean, Molin, Franck, O'Hara, Gilles, Philippon, François, Plourde, Benoit, Sarrazin, Jean-François, Steinberg, Christian, Coufal, Zdenek, Balazsik, David, Mikulica, Michal, Zapeca, Jakub, Cermak, Ondrej, Drasnar, Tomas, Falc, Matej, Hornof, Josef, Racz, Blazej, Weissova, Danica, Linkova, Hana, Paskova, Eva, Petr, Robert, Sirakova, Andrea, Kettner, Jiri, Benak, Ales, Holek, Martin, Podpera, Ivo, Podperova, Monika, Vancura, Vlastimil, Jandik, Tomas, Smid, Jiri, Dedek, Vratislav, Banik, Jan, Durdil, Vaclav, Hnat, Tomas, Lellouche, Nicolas, Rouffiac, Ségolène, Taldir, Guillaume, Bridonneau, Valentin, Couffon, Philippe, Daudin, Magalie, Hamon, Cécile, Lacaze, Jonathan, Quentin, Anne, Thebault, Christophe, Boiffard, Emmanuel, Billon, Olivier, Miette, Fabien, Pouliquen, Hervé, Turlotte, Guillaume, Gorka, Hervé, Albert, Franck, Bayle, Sandrine, Bensaid, Reda, Dasoveanu, Madalina, Demichili, Thibaud, Dutoiu, Teodora, Khalil, Cliff, Loghin, Caterina, Range, Grégoire, Roussel, Laurent, Socié, Pierre, Thuaire, Christophe, Extramiana, Fabrice, Algalarrondo, Vincent, Boughanmi, Haten, El Mansour, Noreddine, Mohammad, Usman, Sellier, Romain, Elbaz, Meyer, Laperche, Clémence, Maury, Philippe, Kiss, Robert, Borsanyi, Tunde, Gingl, Zoltan, Polgar, Balaza, Benczur, Bela, Bodor, Alexandra, Hepp, Tamas, Malati, Eva, Nagy, Laszlo, Erdei, Norbert, Kapus, Jozsef, Kapus, Katalin, Toth, Brigitta, Matoltsy, Andras, Kiss, Tunde, Merkely, Bela, Herczeg, Szilvia, Kiss, Orsolya, Sallo, Zoltan, Toth, Kalman, Habon, Tamas, Rabai, Miklos, Totsimon, Kinga, Zilahi, Zsolt, Bencze, Gabriella, Santa, Janos, Aradi, Daniel, Kelemen, Barbara, Bolognese, Leonardo, Nesti, Martina, Notarstefano, Pasquale Giovanni, D'Orazio, Simona, Cosmi, Franco, Becattini, Cecilia, Agnelli, Giancarlo, Broccatelli, Belinda, Mosconi, Maria Giulia, Paciaroni, Maurizio, Urbini, Chiara, Parato, Vito Maurizio, Notaristefani, Camilla, Scarano, Michele, Ameri, Pietro, Ghigliotti, Giorgio, Guglielmi, Giulia, Lotti, Roberta, Merlo, Andrea Carlo, Muiesan, Maria Lorenza, Abondio, Andrea, Berasi, Caterina, Mattiuzzo, Elena, Mutti, Claudio, Salvetti, Massimo, Pignatelli, Pasquale, Menichelli, Danilo, Pastori, Daniele, Tamiya, Eiji, Matsumoto, Takahiro, Takabe, Tomosato, Yamamoto, Shoichi, Yamashita, Haruyo, Higashiue, Shinichi, Furuya, Onichi, Hiramatsu, Norihiko, Kasuga, Kensuke, Kojima, Saburo, Komooka, Masatoshi, Kuroyanagi, Satoshi, Matsuura, Makoto, Takemoto, Tetsushi, Yamamoto, Shuji, Saito, Katusmi, Abe, Takuro, Ishida, Issei, Iwanami, Yuji, Kataoka, Shohei, Moriyama, Tetsu, Murohashi, Akira, Sasaki, Akihito, Nakamura, Yuichiro, Ueno, Tetsuya, Shimane, Akira, Hamana, Tomoyo, Ichibori, Hirotoshi, Inoue, Tomohiro, Itoh, Mitsuaki, Iwane, Seigo, Kawai, Hiroya, Kokawa, Tatsuya, Masumoto, Akiko, Matsuo, Koki, Miyata, Taishi, Nakano, Shinsuke, Oishi, Shogo, Onishi, Tetsuari, Sawada, Takahiro, Saito, Takayuki, Shoda, Mitsuhiko, Takahashi, Nobuyuki, Takaya, Tomofumi, Taniguchi, Yasuyo, Tsukamoto, Shota, Tsukishiro, Yasue, Tsukiyama, Yoshiro, Tsunamoto, Hiroshi, Uzu, Kenzo, Yamamoto, Hiroyuki, Yamamoto, Tetsuya, Yokoi, Kiminobu, Yoshida, Chiaki, Watanabe, Nobuhiro, Betsuyaku, Tetsuo, Adachi, Kumiko, Awane, Kouichi, Goto, Daisuke, Sakakibara, Mamoru, Watanabe, Masashi, Ueno, Hideki, Hiroe, Yoshitaka, Matsuo, Koshi, Ayata, Kenji, Fukuda, Ko, Hata, Yoshiki, Hashimoto, Katsushi, Matsumi, Hiroaki, Nikaido, Akira, Okamoto, Shuichi, Sime, Iveta, Stirna, Valters, Reinholde, Ilze, Hansone, Silvija, Kozlovska, Anita, Romanova, Janina, Klincare, Dace, Pontaga, Natalja, Dirmans, Igors, Kalnins, Artis, Upite, Dana, Gersamija, Arcils, Teleznikovs, Arturs, Rozkova, Nadezda, Safro, Jelena, Anguera Camós, Ignasi, Domenico Dallaglio, Paolo, Salguero Bodes, Rafael, Arnbas, Fernando, Borrego, Luis, Marco, Alvaro, Jimenez, Javier Ramos, Gómez-Doblas, Juan José, Pérez Cabeza, Alejandro, Ferreira Gonzålez, Ignacio, Limeres Freire, Javier, Lopez Grau, Merce, Viñolas Prat, Xavier, Moreno Weidmann, Zoraida, Guerra Ramos, Jose Maria, Alonso Martin, Maria Concepcion, Campos Garcia, Bieito, Mogro Carranza, Javier Mauricio, Mendez Zurita, Francisco Javier, Rodriguez Font, Enrique, Gonzales Matos, Carlos Eduardo, García Hernando, Víctor, Lindholm, Carl-Johan, Thulin, Jörgen, Wallén, Håkan, Hagwall, Kristina, Eliasson, Ken, Lundvall, Martin, Olsson, Jens, Kjellman, Björn, Lind, Markus, Johansson, Lars, Svedberg, Niclas, Berglund, Stefan, Söderberg, Julia, Zedigh, Christer, Mooe, Thomas, Axelsson, Mattias, Binsell, Emil, Huber, Daniel, Müller, Christian, Danier, Isabelle, Kühne, Michael, Okamura, Bernhard, Schoepfer, Hadrien, Simmen, Cornelia, Reichlin, Tobias, Chollet, Laurève, Lam, Anna, Wittmer, Severin, Rickli, Hans, Gall, Christian, Hametner, Greta, Intorp, Stephanie, Luescher, Daniel, Haegeli, Laurent, Berg, Jan Christopher, Ebrahimi, Ramin, Auricchio, Angelo, Crljenica, Carmela, Moccetti, Tizziano, Monti, Cristina, Pasotti, Elena, Petrova, Iveta, Rossi, Mariagrazia, Mach, François, Namdar, Mehdi, de Groot, Joris, Proost, Virginnio, Neefs, Joline, Linz, Dominik, van Stipdonk, Twan, den Uijl, Dennis, Alings, Marco, Schaap, Jeroen, Segers, Dolf, Wouters, Noemi, Bartels, Louis, Tieleman, Robert, Pisters, Ron, de Vries, Tim, Selig, Jaap, Kuijper, Aaf, Bot, Pieter, Keijzers, Mitran, Verdel, Gerardus, Tukkie, Raymond, van den Bos, Ewout, Kauer, Floris, Oemrawsingh, Rohit, Stevenhagen, Jeroen, van Es, Jan, Lip, Gregory, Gupta, Dhiraj, Kotalczyk, Agnieszka, Gunstone, Anthony, Brixey, Richard David, Gorog, Diana, Dinarvand, Danial, Gue, Ying, Kanji, Rahim, Memtsas, Vassilios, Senior, Roxy, Bioh, Gabriel, Wong, Yuk-Ki, Child, Nick, Piccini, Jonathan P, Caso, Valeria, Connolly, Stuart J, Fox, Keith A A, Oldgren, Jonas, Jones, W Schuyler, Gorog, Diana A, Durdil, Václav, Viethen, Thomas, Neumann, Christoph, Mundl, Hardi, and Patel, Manesh R

Published
2022
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5. Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials

Author

Eikelboom, John W., primary, Mundl, Hardi, additional, Alexander, John H., additional, Caso, Valeria, additional, Connolly, Stuart J., additional, Coppolecchia, Rosa, additional, Gebel, Martin, additional, Hart, Robert G., additional, Holberg, Gerlind, additional, Keller, Lars, additional, Patel, Manesh R., additional, Piccini, Jonathan P., additional, Rao, Sunil V., additional, Shoamanesh, Ashkan, additional, Tamm, Miriam, additional, Viethen, Thomas, additional, Yassen, Ashraf, additional, and Bonaca, Marc P., additional

Published
2024
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10. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF) : a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Author

Piccini, Jonathan P., Caso, Valeria, Connolly, Stuart J., Fox, Keith A. A., Oldgren, Jonas, Jones, W. Schuyler, Gorog, Diana A., Durdil, Václav, Viethen, Thomas, Neumann, Christoph, Mundl, Hardi, Patel, Manesh R., Piccini, Jonathan P., Caso, Valeria, Connolly, Stuart J., Fox, Keith A. A., Oldgren, Jonas, Jones, W. Schuyler, Gorog, Diana A., Durdil, Václav, Viethen, Thomas, Neumann, Christoph, Mundl, Hardi, and Patel, Manesh R.

Abstract

Background Direct-acting oral anticoagulant use for stroke prevention in atrial fibrillation is limited by bleeding concerns. Asundexian, a novel, oral small molecule activated coagulation factor XIa (FXIa) inhibitor, might reduce thrombosis with minimal effect on haemostasis. We aimed to determine the optimal dose of asundexian and to compare the incidence of bleeding with that of apixaban in patients with atrial fibrillation. Methods In this randomised, double-blind, phase 2 dose-finding study, we compared asundexian 20 mg or 50 mg once daily with apixaban 5 mg twice daily in patients aged 45 years or older with atrial fibrillation, a CHA2DS2-VASc score of at least 2 if male or at least 3 if female, and increased bleeding risk. The study was conducted at 93 sites in 14 countries, including 12 European countries, Canada, and Japan. Participants were randomly assigned (1:1:1) to a treatment group using an interactive web response system, with randomisation stratified by whether patients were receiving a direct-acting oral anticoagulant before the study start. Masking was achieved using a double-dummy design, with participants receiving both the assigned treatment and a placebo that resembled the non-assigned treatment. The primary endpoint was the composite of major or clinically relevant non-major bleeding according to International Society on Thrombosis and Haemostasis criteria, assessed in all patients who took at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT04218266, and EudraCT, 2019-002365-35. Findings Between Jan 30, 2020, and June 21, 2021, 862 patients were enrolled. 755 patients were randomly assigned to treatment. Two patients (assigned to asundexian 20 mg) never took any study medication, resulting in 753 patients being included in the analysis (249 received asundexian 20 mg, 254 received asundexian 50 g, and 250 received apixaban). The mean age of participants was 73·7 years (SD 8·3), 309 (41%) were women, 216

Published
2022
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11. Safety of the oral factor XIa inhibitor asundexian compared with apixaban in patients with atrial fibrillation (PACIFIC-AF): a multicentre, randomised, double-blind, double-dummy, dose-finding phase 2 study

Author

Piccini, Jonathan P, primary, Caso, Valeria, additional, Connolly, Stuart J, additional, Fox, Keith A A, additional, Oldgren, Jonas, additional, Jones, W Schuyler, additional, Gorog, Diana A, additional, Durdil, Václav, additional, Viethen, Thomas, additional, Neumann, Christoph, additional, Mundl, Hardi, additional, Patel, Manesh R, additional, Auer, Johann, additional, Hubauer, Martin, additional, Pandzic, Sead, additional, Preishuber, Eva, additional, Primus-Grabscheit, Carina, additional, Reitgruber, Dietmar, additional, Schmalzer, Florian, additional, Adlbrecht, Christopher, additional, Schober, Andreas, additional, Hajos, Johannes, additional, Keil, Christoph, additional, Schratter, Alexandra, additional, Frick, Matthias, additional, Benda, Magdalena Anna, additional, Mächler, Maximilian, additional, Mutschlechner, Beatrix, additional, Saely, Christoph, additional, Sprenger, Lukas, additional, Lichtenauer, Michael, additional, Eber, Miriam, additional, Hoppe, Uta, additional, Kolbitsch, Tobias, additional, Jirak, Peter Michael, additional, Mirna, Moritz, additional, Schönbauer, Robert, additional, Bergler-Klein, Jutta, additional, Hengstenberg, Christian, additional, Stojkovic, Stefan, additional, Scherr, Daniel, additional, Manninger-Wünscher, Martin, additional, Rohrer, Ursula, additional, Stühlinger, Markus, additional, Schgoer, Wilfried, additional, Schwarzl, Jana, additional, Pürerfellner, Helmut, additional, Derndorfer, Michael, additional, Ebner, Christian, additional, Eder, Veronika, additional, Kollias, Georgios, additional, Sturmberger, Thomas, additional, Sieghartsleitner, Stefan, additional, Vijgen, Johan, additional, Koopman, Peter, additional, Dujardin, Karl, additional, Anné, Wim, additional, De Ceuninck, Michel, additional, Tavernier, Rene, additional, Duytschaever, Mattias, additional, Knecht, Sébastien, additional, Missault, Luc, additional, Vandekerckhove, Yves, additional, Rossenbacker, Tom, additional, Ector, Bavo, additional, Charlier, Filip, additional, Debruyne, Philippe, additional, Dewilde, Willem, additional, Janssens, Luc, additional, Roosen, John, additional, Vankelecom, Bart, additional, Heidbuchel, Hein, additional, Delesie, Michiel, additional, Vervoort, Gert, additional, Rombouts, Hans, additional, Vanassche, Thomas, additional, Engelen, Matthias, additional, Verhamme, Peter, additional, Willems, Rik, additional, Constance, Christian, additional, Pranno, Nicolas, additional, Cox, Jafna, additional, Bata, Iqbal, additional, Macle, Laurent, additional, Aguilar, Martin, additional, Tourigny, Julia Cadrin, additional, Dubuc, Marc, additional, Dyrda, Katia, additional, Guerra, Peter, additional, Khairy, Paul, additional, Mondésert, Blandine, additional, Rivard, Léna, additional, Roy, Denis, additional, Tadros, Rafik, additional, Talajic, Mario, additional, Thibault, Bernard, additional, Nault, Isabelle, additional, Blier, Louis, additional, Champagne, Jean, additional, Molin, Franck, additional, O'Hara, Gilles, additional, Philippon, François, additional, Plourde, Benoit, additional, Sarrazin, Jean-François, additional, Steinberg, Christian, additional, Coufal, Zdenek, additional, Balazsik, David, additional, Mikulica, Michal, additional, Zapeca, Jakub, additional, Cermak, Ondrej, additional, Drasnar, Tomas, additional, Falc, Matej, additional, Hornof, Josef, additional, Racz, Blazej, additional, Weissova, Danica, additional, Linkova, Hana, additional, Paskova, Eva, additional, Petr, Robert, additional, Sirakova, Andrea, additional, Kettner, Jiri, additional, Benak, Ales, additional, Holek, Martin, additional, Podpera, Ivo, additional, Podperova, Monika, additional, Vancura, Vlastimil, additional, Jandik, Tomas, additional, Smid, Jiri, additional, Dedek, Vratislav, additional, Banik, Jan, additional, Durdil, Vaclav, additional, Hnat, Tomas, additional, Lellouche, Nicolas, additional, Rouffiac, Ségolène, additional, Taldir, Guillaume, additional, Bridonneau, Valentin, additional, Couffon, Philippe, additional, Daudin, Magalie, additional, Hamon, Cécile, additional, Lacaze, Jonathan, additional, Quentin, Anne, additional, Thebault, Christophe, additional, Boiffard, Emmanuel, additional, Billon, Olivier, additional, Miette, Fabien, additional, Pouliquen, Hervé, additional, Turlotte, Guillaume, additional, Gorka, Hervé, additional, Albert, Franck, additional, Bayle, Sandrine, additional, Bensaid, Reda, additional, Dasoveanu, Madalina, additional, Demichili, Thibaud, additional, Dutoiu, Teodora, additional, Khalil, Cliff, additional, Loghin, Caterina, additional, Range, Grégoire, additional, Roussel, Laurent, additional, Socié, Pierre, additional, Thuaire, Christophe, additional, Extramiana, Fabrice, additional, Algalarrondo, Vincent, additional, Boughanmi, Haten, additional, El Mansour, Noreddine, additional, Mohammad, Usman, additional, Sellier, Romain, additional, Elbaz, Meyer, additional, Laperche, Clémence, additional, Maury, Philippe, additional, Kiss, Robert, additional, Borsanyi, Tunde, additional, Gingl, Zoltan, additional, Polgar, Balaza, additional, Benczur, Bela, additional, Bodor, Alexandra, additional, Hepp, Tamas, additional, Malati, Eva, additional, Nagy, Laszlo, additional, Erdei, Norbert, additional, Kapus, Jozsef, additional, Kapus, Katalin, additional, Toth, Brigitta, additional, Matoltsy, Andras, additional, Kiss, Tunde, additional, Merkely, Bela, additional, Herczeg, Szilvia, additional, Kiss, Orsolya, additional, Sallo, Zoltan, additional, Toth, Kalman, additional, Habon, Tamas, additional, Rabai, Miklos, additional, Totsimon, Kinga, additional, Zilahi, Zsolt, additional, Bencze, Gabriella, additional, Santa, Janos, additional, Aradi, Daniel, additional, Kelemen, Barbara, additional, Bolognese, Leonardo, additional, Nesti, Martina, additional, Notarstefano, Pasquale Giovanni, additional, D'Orazio, Simona, additional, Cosmi, Franco, additional, Becattini, Cecilia, additional, Agnelli, Giancarlo, additional, Broccatelli, Belinda, additional, Mosconi, Maria Giulia, additional, Paciaroni, Maurizio, additional, Urbini, Chiara, additional, Parato, Vito Maurizio, additional, Notaristefani, Camilla, additional, Scarano, Michele, additional, Ameri, Pietro, additional, Ghigliotti, Giorgio, additional, Guglielmi, Giulia, additional, Lotti, Roberta, additional, Merlo, Andrea Carlo, additional, Muiesan, Maria Lorenza, additional, Abondio, Andrea, additional, Berasi, Caterina, additional, Mattiuzzo, Elena, additional, Mutti, Claudio, additional, Salvetti, Massimo, additional, Pignatelli, Pasquale, additional, Menichelli, Danilo, additional, Pastori, Daniele, additional, Tamiya, Eiji, additional, Matsumoto, Takahiro, additional, Takabe, Tomosato, additional, Yamamoto, Shoichi, additional, Yamashita, Haruyo, additional, Higashiue, Shinichi, additional, Furuya, Onichi, additional, Hiramatsu, Norihiko, additional, Kasuga, Kensuke, additional, Kojima, Saburo, additional, Komooka, Masatoshi, additional, Kuroyanagi, Satoshi, additional, Matsuura, Makoto, additional, Takemoto, Tetsushi, additional, Yamamoto, Shuji, additional, Saito, Katusmi, additional, Abe, Takuro, additional, Ishida, Issei, additional, Iwanami, Yuji, additional, Kataoka, Shohei, additional, Moriyama, Tetsu, additional, Murohashi, Akira, additional, Sasaki, Akihito, additional, Nakamura, Yuichiro, additional, Ueno, Tetsuya, additional, Shimane, Akira, additional, Hamana, Tomoyo, additional, Ichibori, Hirotoshi, additional, Inoue, Tomohiro, additional, Itoh, Mitsuaki, additional, Iwane, Seigo, additional, Kawai, Hiroya, additional, Kokawa, Tatsuya, additional, Masumoto, Akiko, additional, Matsuo, Koki, additional, Miyata, Taishi, additional, Nakano, Shinsuke, additional, Oishi, Shogo, additional, Onishi, Tetsuari, additional, Sawada, Takahiro, additional, Saito, Takayuki, additional, Shoda, Mitsuhiko, additional, Takahashi, Nobuyuki, additional, Takaya, Tomofumi, additional, Taniguchi, Yasuyo, additional, Tsukamoto, Shota, additional, Tsukishiro, Yasue, additional, Tsukiyama, Yoshiro, additional, Tsunamoto, Hiroshi, additional, Uzu, Kenzo, additional, Yamamoto, Hiroyuki, additional, Yamamoto, Tetsuya, additional, Yokoi, Kiminobu, additional, Yoshida, Chiaki, additional, Watanabe, Nobuhiro, additional, Betsuyaku, Tetsuo, additional, Adachi, Kumiko, additional, Awane, Kouichi, additional, Goto, Daisuke, additional, Sakakibara, Mamoru, additional, Watanabe, Masashi, additional, Ueno, Hideki, additional, Hiroe, Yoshitaka, additional, Matsuo, Koshi, additional, Ayata, Kenji, additional, Fukuda, Ko, additional, Hata, Yoshiki, additional, Hashimoto, Katsushi, additional, Matsumi, Hiroaki, additional, Nikaido, Akira, additional, Okamoto, Shuichi, additional, Sime, Iveta, additional, Stirna, Valters, additional, Reinholde, Ilze, additional, Hansone, Silvija, additional, Kozlovska, Anita, additional, Romanova, Janina, additional, Klincare, Dace, additional, Pontaga, Natalja, additional, Dirmans, Igors, additional, Kalnins, Artis, additional, Upite, Dana, additional, Gersamija, Arcils, additional, Teleznikovs, Arturs, additional, Rozkova, Nadezda, additional, Safro, Jelena, additional, Anguera Camós, Ignasi, additional, Domenico Dallaglio, Paolo, additional, Salguero Bodes, Rafael, additional, Arnbas, Fernando, additional, Borrego, Luis, additional, Marco, Alvaro, additional, Jimenez, Javier Ramos, additional, Gómez-Doblas, Juan José, additional, Pérez Cabeza, Alejandro, additional, Ferreira Gonzålez, Ignacio, additional, Limeres Freire, Javier, additional, Lopez Grau, Merce, additional, Viñolas Prat, Xavier, additional, Moreno Weidmann, Zoraida, additional, Guerra Ramos, Jose Maria, additional, Alonso Martin, Maria Concepcion, additional, Campos Garcia, Bieito, additional, Mogro Carranza, Javier Mauricio, additional, Mendez Zurita, Francisco Javier, additional, Rodriguez Font, Enrique, additional, Gonzales Matos, Carlos Eduardo, additional, García Hernando, Víctor, additional, Lindholm, Carl-Johan, additional, Thulin, Jörgen, additional, Wallén, Håkan, additional, Hagwall, Kristina, additional, Eliasson, Ken, additional, Lundvall, Martin, additional, Olsson, Jens, additional, Kjellman, Björn, additional, Lind, Markus, additional, Johansson, Lars, additional, Svedberg, Niclas, additional, Berglund, Stefan, additional, Söderberg, Julia, additional, Zedigh, Christer, additional, Mooe, Thomas, additional, Axelsson, Mattias, additional, Binsell, Emil, additional, Huber, Daniel, additional, Müller, Christian, additional, Danier, Isabelle, additional, Kühne, Michael, additional, Okamura, Bernhard, additional, Schoepfer, Hadrien, additional, Simmen, Cornelia, additional, Reichlin, Tobias, additional, Chollet, Laurève, additional, Lam, Anna, additional, Wittmer, Severin, additional, Rickli, Hans, additional, Gall, Christian, additional, Hametner, Greta, additional, Intorp, Stephanie, additional, Luescher, Daniel, additional, Haegeli, Laurent, additional, Berg, Jan Christopher, additional, Ebrahimi, Ramin, additional, Auricchio, Angelo, additional, Crljenica, Carmela, additional, Moccetti, Tizziano, additional, Monti, Cristina, additional, Pasotti, Elena, additional, Petrova, Iveta, additional, Rossi, Mariagrazia, additional, Mach, François, additional, Namdar, Mehdi, additional, de Groot, Joris, additional, Proost, Virginnio, additional, Neefs, Joline, additional, Linz, Dominik, additional, van Stipdonk, Twan, additional, den Uijl, Dennis, additional, Alings, Marco, additional, Schaap, Jeroen, additional, Segers, Dolf, additional, Wouters, Noemi, additional, Bartels, Louis, additional, Tieleman, Robert, additional, Pisters, Ron, additional, de Vries, Tim, additional, Selig, Jaap, additional, Kuijper, Aaf, additional, Bot, Pieter, additional, Keijzers, Mitran, additional, Verdel, Gerardus, additional, Tukkie, Raymond, additional, van den Bos, Ewout, additional, Kauer, Floris, additional, Oemrawsingh, Rohit, additional, Stevenhagen, Jeroen, additional, van Es, Jan, additional, Lip, Gregory, additional, Gupta, Dhiraj, additional, Kotalczyk, Agnieszka, additional, Gunstone, Anthony, additional, Brixey, Richard David, additional, Gorog, Diana, additional, Dinarvand, Danial, additional, Gue, Ying, additional, Kanji, Rahim, additional, Memtsas, Vassilios, additional, Senior, Roxy, additional, Bioh, Gabriel, additional, Wong, Yuk-Ki, additional, and Child, Nick, additional

Published
2022
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13. Ferric carboxymaltose in patients with pulmonary arterial hypertension and iron deficiency: a long-term study

Author

Kramer, Tilmann, Wissmueller, Max, Natsina, Kristiana, Gerhardt, Felix, ten Freyhaus, Henrik, Dumitrescu, Daniel, Viethen, Thomas, Hellmich, Martin, Baldus, Stephan, Rosenkranz, Stephan, Kramer, Tilmann, Wissmueller, Max, Natsina, Kristiana, Gerhardt, Felix, ten Freyhaus, Henrik, Dumitrescu, Daniel, Viethen, Thomas, Hellmich, Martin, Baldus, Stephan, and Rosenkranz, Stephan

Abstract

Background Pulmonary arterial hypertension (PAH) is a progressive disease with limited survival. Iron deficiency (ID) correlates with disease severity and mortality. While oral iron supplementation was shown to be insufficient in such patients, the potential impact of parenteral iron on clinical measures warrants further investigation. Methods We retrospectively analysed the long-term effects of intravenous ferric carboxymaltose (FCM) on iron status and clinical measures in patients with PAH and ID [ferritin < 100 mu g/L or ferritin 100-300 mu g/L and transferrin saturation (TSAT) < 20%] who were on stable targeted PAH therapy, compared with matched controls without ID. Patients with ID received a single infusion of FCM (500 to 1000 mg). Clinical measures monitored included exercise capacity, World Health Organization (WHO) functional class, ESC/ERS risk status, and hospitalizations. The observation period was up to 18 months. Results One hundred and seventeen patients (mean age 60.9 +/- 16.1 years; 64.1% females) with confirmed PAH and on stable targeted therapy for >= 3 months were included (58 with and 59 patients without ID who did not receive FCM). In patients with ID, iron supplementation with FCM resulted in an immediate and sustained improvement of iron status for up to 18 months (serum iron, ferritin, TSAT, all P < 0.01). Fourteen patients in the FCM group received a second FCM infusion after 9.6 +/- 4.8 months due to recurrent ID. At 6 and 18 months after FCM infusion, 6 min walk distance improved from 377.5 +/- 15.9 at baseline to 412.5 +/- 15.1 and 400.8 +/- 14.5 m, respectively (both P < 0.05). WHO functional class (P < 0.05) and ESC/ERS risk status also improved, and there was a reduction of hospitalizations for worsening PAH in the 12 months post vs. prior to iron repletion (P = 0.029). No significant changes were observed in the control group. FCM was well tolerated in all patients, with no severe adverse events. Conclusions In addition to targeted t

Published
2021

14. Real-Life Multimarker Monitoring in Patients with Heart Failure: Continuous Remote Monitoring of Mobility and Patient-Reported Outcomes as Digital End Points in Future Heart-Failure Trials

Author

Kramer, Frank, primary, Butler, Javed, additional, Shah, Sanjiv J., additional, Jung, Christian, additional, Nodari, Savina, additional, Rosenkranz, Stephan, additional, Senni, Michele, additional, Bamber, Luke, additional, Cichos, Stephan, additional, Dori, Chrysanthi, additional, Karakoyun, Toeresin, additional, Köhler, Gabriele Jenny, additional, Patel, Kinjal, additional, Piraino, Paolo, additional, Viethen, Thomas, additional, Chennuru, Praneeth, additional, Paydar, Ayse, additional, Sims, Jason, additional, Clark, Richard, additional, van Lummel, Rob, additional, Müller, Alexandra, additional, Gwaltney, Chad, additional, Smajlovic, Salko, additional, Düngen, Hans-Dirk, additional, and Dinh, Wilfried, additional

Published
2020
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17. Oscillatory whole-body vibration improves exercise capacity and physical performance in pulmonary arterial hypertension: a randomised clinical study

Author

Gerhardt, Felix, Dumitrescu, Daniel, Gaertner, Carina, Beccard, Ralf, Viethen, Thomas, Kramer, Tilmann, Baldus, Stephan, Hellmich, Martin, Schoenau, Eckhard, Rosenkranz, Stephan, Gerhardt, Felix, Dumitrescu, Daniel, Gaertner, Carina, Beccard, Ralf, Viethen, Thomas, Kramer, Tilmann, Baldus, Stephan, Hellmich, Martin, Schoenau, Eckhard, and Rosenkranz, Stephan

Abstract

Objective In patients with pulmonary arterial hypertension ( PAH), supportive therapies may be beneficial in addition to targeted medical treatment. Here, we evaluated the effectiveness and safety of oscillatory whole-body vibration (WBV) in patients on stable PAH therapy. Methods Twenty-two patients with PAH (mean PAP >= 25 mm Hg and pulmonary arterial wedge pressure (PAWP)<= 15 mm Hg) who were in world health organization (WHO)-Functional Class II or III and on stable PAH therapy for >= 3 months, were randomised to receive WBV (16 sessions of 1-hour duration within 4 weeks) or to a control group, that subsequently received WBV. Follow-up measures included the 6-min walking distance (6MWD), cardiopulmonary exercise testing (CPET), echocardiography, muscle-power, and health-related quality of life (HRQoL; SF-36 and LPH questionnaires). Results When compared to the control group, patients receiving WBV exhibited a significant improvement in the primary endpoint, the 6MWD (+ 35.4 +/- 10.9 vs -4.4 +/- 7.6 m), resulting in a net benefit of 39.7 +/- 7.8m (p= 0.004). WBV was also associated with substantial improvements in CPET variables, muscle power, and HRQoL. The combined analysis of all patients (n= 22) indicated significant net improvements versus baseline in the 6MWD (+ 38.6 m), peakVO2 (+ 65.7 mL/min), anaerobic threshold (+ 40.9 mL VO2/min), muscle power (+ 4.4%), and HRQoL (SF-36 + 9.7, LPH -11.5 points) (all p< 0.05). WBV was well tolerated in all patients, and no procedure-related severe adverse events (SAEs) occurred. Conclusions WBV substantially improves exercise capacity, physical performance, and HRQoL in patients with PAH who are on stable targeted therapy. This methodology may be utilised in structured training programmes, and may be feasible for continuous long-term physical exercise in these patients.

Published
2017

18. Oscillatory whole-body vibration improves exercise capacity and physical performance in pulmonary arterial hypertension: a randomised clinical study

Author

Gerhardt, Felix, primary, Dumitrescu, Daniel, additional, Gärtner, Carina, additional, Beccard, Ralf, additional, Viethen, Thomas, additional, Kramer, Tilmann, additional, Baldus, Stephan, additional, Hellmich, Martin, additional, Schönau, Eckhard, additional, and Rosenkranz, Stephan, additional

Published
2017
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19. Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial

Author

Gruenig, Ekkehard, Benjamin, Nicola, Lange, Tobias J., Krueger, Ulrich, Klose, Hans, Neurohr, Claus, Wilkens, Heinrike, Halank, Michael, Seyfarth, Hans-Juergen, Held, Matthias, Traube, Andrew, Pernow, Michelle, Grover, E. Robert, Egenlauf, Benjamin, Gerhardt, Felix, Viethen, Thomas, Rosenkranz, Stephan, Gruenig, Ekkehard, Benjamin, Nicola, Lange, Tobias J., Krueger, Ulrich, Klose, Hans, Neurohr, Claus, Wilkens, Heinrike, Halank, Michael, Seyfarth, Hans-Juergen, Held, Matthias, Traube, Andrew, Pernow, Michelle, Grover, E. Robert, Egenlauf, Benjamin, Gerhardt, Felix, Viethen, Thomas, and Rosenkranz, Stephan

Abstract

Background: Subcutaneous treprostinil has dose-dependent beneficial effects in patients with severe pulmonary arterial hypertension, but adverse effects like infusion site pain can lead to treatment discontinuation. Objectives: The objective of this study was to evaluate safety, tolerability and clinical effects of a rapid up-titration dosing regimen of subcutaneous treprostinil using proactive infusion site pain management. Methods: Effects of rapid up-titration dosing regimen on tolerability and clinical parameters were evaluated in this 16-week, open-label multi-centre study. Results: Thirty-nine patients with idiopathic or heritable pulmonary arterial hypertension on stable treatment with oral pulmonary arterial hypertension-approved drugs (90% on dual combination therapy) were included. Patients achieved a median treprostinil dosage of 35.7 ng/kg/min after 16 weeks. A good overall safety profile was demonstrated with 3 patients (8%) withdrawing due to infusion site pain, which occurred in 97% of patients. After 16 weeks, median 6-min walking distance, cardiac index, pulmonary vascular resistance, and tricuspid annular plane systolic excursion improved. Conclusions: Rapid up-titration of subcutaneous treprostinil was well tolerated, achieving a clinically effective dose associated with improvement of exercise capacity and haemodynamics after 16 weeks. A rapid dose titration regimen and proactive infusion site pain management may improve the handling of this therapy and contribute to better treatment outcome. (C) 2016 S. Karger AG, Basel.

Published
2016

20. Case report: Subjective loss of performance after pulmonary embolism in an athlete-beyond normal values

Author

Dumitrescu, Daniel, Gerhardt, Felix, Viethen, Thomas, Schmidt, Matthias, Mayer, Eckhard, Rosenkranz, Stephan, Dumitrescu, Daniel, Gerhardt, Felix, Viethen, Thomas, Schmidt, Matthias, Mayer, Eckhard, and Rosenkranz, Stephan

Abstract

Background: Chronic thromboembolic pulmonary hypertension (CTEPH) is a progressive disease. For patients with operable CTEPH, there is a clear recommendation for surgical removal of persistent thrombi by pulmonary endarterectomy (PEA). However, without the presence of PH, therapeutic management of chronic thromboembolic disease (CTED) is challenging - especially in highly trained subjects exceeding predicted values of maximal exercise capacity. Case presentation: A 43-year-old male athlete reported with progressive exercise limitation since 8 months. Six months earlier, pulmonary embolism had occurred, and was treated since with oral anticoagulation. A pulmonary ventilation/perfusion scan showed severe ventilation/perfusion mismatch: chest CT and pulmonary angiography revealed bilateral wall-adherent thrombotic material, but pulmonary hemodynamics were completely normal. His peak oxygen uptake exceeded predicted values, however exercise ventilatory efficiency was abnormal, compared to a matching athlete. After thoroughly discussing therapeutic options with the patient, he successfully underwent pulmonary endarterectomy at an expert center. Five and twelve months after surgery, his maximal exercise capacity and ventilatory efficiency profoundly improved beyond preoperative values, and his subjective exercise tolerance had returned to normal. Conclusions: Significant CTED may be present without relevant pathologic changes in pulmonary hemodynamics at rest. Reaching normal values of maximal exercise capacity does not exclude pulmonary vascular disease in highly trained subjects. More data are needed to evaluate the risk-/benefit ratio of PEA in patients with CTED and normal pulmonary hemodynamics. A thorough discussion with the patient as well as shared decision making regarding therapy are mandatory. Cardiopulmonary exercise testing may add important clinical information in the non-invasive diagnostic evaluation at baseline and during follow-up.

Published
2016

24. Safety, Tolerability and Clinical Effects of a Rapid Dose Titration of Subcutaneous Treprostinil Therapy in Pulmonary Arterial Hypertension: A Prospective Multi-Centre Trial

Author

Grünig, Ekkehard, primary, Benjamin, Nicola, additional, Lange, Tobias J., additional, Krueger, Ulrich, additional, Klose, Hans, additional, Neurohr, Claus, additional, Wilkens, Heinrike, additional, Halank, Michael, additional, Seyfarth, Hans-Jürgen, additional, Held, Matthias, additional, Traube, Andrew, additional, Pernow, Michelle, additional, Grover, E. Robert, additional, Egenlauf, Benjamin, additional, Gerhardt, Felix, additional, Viethen, Thomas, additional, and Rosenkranz, Stephan, additional

Published
2016
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27. Abstract 12081: Beneficial Effects of Ferric Carboxymaltose in Patients With Pulmonary Arterial Hypertension and Iron Deficiency: A Long-term Study

Author

Kramer, Tilmann T, Viethen, Thomas, Natsina, Kristiana, Gerhardt, Felix, Ten-Freyhaus, Henrik, Dumitrescu, Daniel, Hellmich, Martin, Baldus, Stephan, and Rosenkranz, Stephan

Abstract

Introduction:PAH is a progressive disease with limited prognosis. Iron deficiency (ID) correlates in PAH patients with disease severity and mortality. Oral iron resorption is impaired by hepcidine in PAH. In a former pilot study, we could demonstrate a short-term benefit of i.v. iron substitution on exercise tolerance and quality of life. Subsequently, in this study we examined the effects of i.v. ferric carboxymaltose (FCM) in patients with PAH and ID for a period up to 15 months.Hypothesis:We hypothesized that there are beneficial long-term effects in these patients on exercise tolerance and right heart function.Methods:64 patients with PAH and ID (serum iron < 10 ?mol/L, ferritin <150 ?g/L and transferrin saturation [TSAT] <15%), who were on a stable PAH therapy for ? 3 months, received FCM in a mean dosage of 914.1 ? 165.8 mg during the 15-month observation period. Twenty PAH patients without ID who did not receive FCM, served as matched controls. Follow-up included iron status, WHO functional class (WHO-FC), 6-minute walk distance (6MWD), echocardiography and NTproBNP levels.Results:All patients in the intervention group obtained i.v. iron supplementation with FCM at baseline. 11 patients received a second FCM infusion, of which 2 patients needed a maximum of 3 FCM infusions due to re-occurence of ID. In patients with ID, FCM infusion resulted in an immediate and sustained improvement of iron status (serum iron, ferritin, TSAT, all p<0.05) during the course of our study. 2 months after the first FCM infusion, 6MWD improved from 354.9 ? 15.8 to 380.4 ? 14.7 m (p=0.016), which increased after 15 months to 389.6 ? 14.1 m. Also WHO-FC and NTproBNP levels improved. NTproBNP levels declined from 1423 ? 264 to 1062 ? 271 ng/L at 15 months. No significant changes were observed in the control group. After FCM administration no severe adverse events occured, only minimal side effects were observed.Conclusions:Parenteral iron repletion with FCM was well tolerated in addition to targeted PAH therapy and led to beneficial long-term effects on excercice capacity, WHO-FC, NTproBNP serum levels, and risk stratification in PAH patients with ID. The results provide a promising basis for future, controlled studies on the long-term effect of supportive iron supplementation in PAH.

Published
2019
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28. Asundexian versus Apixaban in Patients with Atrial Fibrillation.

Author

Piccini JP, Patel MR, Steffel J, Ferdinand K, Van Gelder IC, Russo AM, Ma CS, Goodman SG, Oldgren J, Hammett C, Lopes RD, Akao M, De Caterina R, Kirchhof P, Gorog DA, Hemels M, Rienstra M, Jones WS, Harrington J, Lip GYH, Ellis SJ, Rockhold FW, Neumann C, Alexander JH, Viethen T, Hung J, Coppolecchia R, Mundl H, and Caso V

Subjects
Aged, Aged, 80 and over, Female, Humans, Male, Administration, Oral, Double-Blind Method, Factor Xa Inhibitors administration & dosage, Factor Xa Inhibitors adverse effects, Hydrocarbons, Fluorinated, Intention to Treat Analysis, Pyrazoles administration & dosage, Pyrazoles adverse effects, Pyridones administration & dosage, Pyridones adverse effects, Benzamides administration & dosage, Benzamides adverse effects, Triazoles administration & dosage, Triazoles adverse effects, Anticoagulants administration & dosage, Anticoagulants adverse effects, Atrial Fibrillation drug therapy, Atrial Fibrillation complications, Embolism epidemiology, Embolism etiology, Embolism prevention & control, Hemorrhage chemically induced, Hemorrhage epidemiology, Stroke epidemiology, Stroke etiology, Stroke prevention & control
Abstract

Background: Stroke prevention with direct-acting oral anticoagulant agents in patients with atrial fibrillation confers a risk of bleeding and limits their use. Asundexian, an activated factor XI (XIa) inhibitor, is an oral anticoagulant that may prevent strokes with less bleeding., Methods: In a phase 3, international, double-blind trial, we randomly assigned high-risk patients with atrial fibrillation in a 1:1 ratio to receive asundexian at a dose of 50 mg once daily or standard-dose apixaban. The primary efficacy objective was to determine whether asundexian is at least noninferior to apixaban for the prevention of stroke or systemic embolism. The primary safety objective was to determine whether asundexian is superior to apixaban with respect to major bleeding events., Results: A total of 14,810 randomly assigned patients were included in the intention-to-treat population. The mean (±SD) age of the patients was 73.9±7.7 years, 35.2% were women, 18.6% had chronic kidney disease, 18.2% had a previous stroke or transient ischemic attack, 16.8% had received oral anticoagulants for no more than 6 weeks, and the mean CHA 2 DS 2 -VASc score (range, 0 to 9, with higher scores indicating a greater risk of stroke) was 4.3±1.3. The trial was stopped prematurely at the recommendation of the independent data monitoring committee. Stroke or systemic embolism occurred in 98 patients (1.3%) assigned to receive asundexian and in 26 (0.4%) assigned to receive apixaban (hazard ratio, 3.79; 95% confidence interval [CI], 2.46 to 5.83). Major bleeding occurred in 17 patients (0.2%) who received asundexian and in 53 (0.7%) who received apixaban (hazard ratio, 0.32; 95% CI, 0.18 to 0.55). The incidence of any adverse event appeared to be similar in the two groups., Conclusions: Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time. (Funded by Bayer; OCEANIC-AF ClinicalTrials.gov number, NCT05643573; EudraCT number, 2022-000758-28.)., (Copyright © 2024 Massachusetts Medical Society.)

Published
2025
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