Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure: Outcome study with Tolvaptan (EVEREST)

Mihai Gheorghiade, Cesare Orlandi, John C. Burnett, David Demets, Liliana Grinfeld, Aldo Maggioni, Karl Swedberg, James E. Udelson, Faiez Zannad, Christopher Zimmer, Marvin A. Konstam, M. C. Bahit, M. Haass, P. E. Carson, P. J. Hauptman, M. Metra, A. Miller, C. O’connor, R. M. Oren, R. PattenIleana L. Pina, Sherryn Roth, J. Sackner-Bernstein, H. Dargie, D. L. Demets, K. Dickstein, B. Greenberg, S. Goldstein, J. Lerman, B. Massie, B. Pitt, J. Ouyang, J. Udelson, H. A. Dieterich, Z. Capkova, F. Gadaleta, M. Mule, M. B. Pricipato, Martin Bilsker, Timothy Bishop, Dennis Bresnahan, David Caskey, Andrew Chai, Eugene Chung, Robert Mel Clark, William Dec, Gary Fishbein, Scott Friedman, Jalal Ghali, Alan Gradman, David Richards, Connor Haugh, David Hinchman, Hassan Ibrahim, Michael Imburgia, Eli Roth, Rafael Sequeira, Robert Siegel, Phil Stockwell, Kris Vijay, Tania Nanevicz, Robert Weiss, Richard Wright, Jay Alexander, Larry Altschul, Mohammad Ashraf, James Bergin, Chris Brown, Robert Capodilupo, Robert Carhart, James Carley, Barry Clemson, Terence Connelly, John Corbelli, Robert Doroghazi, Eric Eichhorn, Mahfouz El-Shahawy, John Foley, Mark Goldberg, David Goldscher, Steven Goldsmith, Terrence Hack, Ethan Haskel, David Hassel, Paul Hauptman, Pamela Rama, Philip Houck, Donald Jansen, Scott Jerome, Yamil Aude, David Joyce, Richard Kachel, Shaival Kapadia, Robert Kipperman, Richard Krasuski, Marvin Kronenberg, Farhad Aduli, Michael Liston, James Hodsen, James McCriskin, Frank McGrew, Robert Shor, Karan Munuswamy, Puneet Narayan, Imran Niazi, E. Dean Nukta, John O’brien, Joseph O’bryan, Maria Teresa Olivari, Mary Ann Peberdy, Mark Jeffrey Pirwitz, Rakesh Prashad, David Rubin, Jonathan Safren, Mitchell Saltzberg, Gregg Schuyler, Jonathan Roberts, Bramah Singh, Rodolfo Sotolongo, David Stagaman, Dwight Stapleton, William Van Decker, Charles Wilkins, Mohamad El-Zaru, Brian Kahn, Joseph Lash, John Banas, Supratim Banerjee, Marlo Leonen, Raymond Benza, Harry Colfer, Edouard Daher, Peter Fattal, Jack Foster, Peter Goodfield, Dinesh Gupta, William Hathaway, Herbert Haught, Tetsuo Ishimori, Bruce Iteld, Michael Kesselbrenner, Marc Klapholz, Peter McCullough, John Cieszkowski, Edward McMillan, Andrew Boyle, Mark Nathan, Terrence O’brien, Gary Felker, William Oellerich, Naveen Pereira, James Sandberg, Ernst Schwarz, Ralph Vicari, Frederick Whittier, Rene Alvarez, Alan Bank, Fred Cobb, David Cullinane, Himadri Dasgupta, J. T. Heywood, Steve Krueger, Brian Lowes, Jack Rose, Joel Sklar, J. Thomas Suh, Nampalli Vijay, Mary Walsh, Doug Chapman, Justine Lachmann, John Gordon, David Kraus, Brent Devries, Kirk Adams, Rachel Bijou, Uri Elkayam, Kenneth Fath, Hillel Ribner, John Schmedtje, Bruce Jackson, Joseph Wight, Michael Miyamoto, Hal Skopicki, Robert Frantz, Marrick Kukin, John McBride, Lana Tsao, Richard Ryder, Michael Koren, Kenneth Taylor, Kathy Hebert, Mara Slawsky, Narendra Singh, Christopher Brian, Syed Jafri, David Smith, Van Stephen Monroe, Mitchell Greenspan, Marc Silver, Lynne Wagoner, Ricky Schneider, Robert Moskowitz, Muhammad Yasin, Douglas Waldo, Tali Arik, Anique Ducharme, Bruce Sussex, Asaad Bakbak, David Borts, Y. K. Chan, L. John Charles, Nadia Giannetti, J. E. Goode, W. Peter Klinke, Jan Kornder, Peter Giannoccaro, Simon Kouz, Jacques Lenis, Serge Lepage, Gordon Moe, Andrew Morris, Yves Pesant, Diego Delgado, Thao Huynh, Patrick Ma, Frank Halperin, Thomas Rebane, A. S. Pandey, Jorge Tronge, Norberto Vulcano, Julio Jorge Bluguermann, Miguel Angel Riccitelli, Sergio Martin Chekherdemian, Roberto Colque, Marcos Amuchastegui, Eduardo Roque Perna, Aristóbulo Enrique Ballestrini, Alejandro Posadas, Ana Maria Salvatti, Luis Girotti, Susana Llois, Monica Sultan, Oscar Grosso, Carlos Estrada, Simón Mario Salzberg, Daniel Nul, Luis Guzmán, Marcelo Halac, Sergio Perrone, Alvaro Sosa Liprandi, Antonio Carlos Pereira Barreto, Celso Blacher, Euler Roberto Fernandes, Gilson Soares Feitosa, Gilmar Valdir Greque, Gilmar Reis, José Marcio Ribeiro, Lilia Nigro Maia, Pedro Pimentel Filho, Salvador Rassi, Paulo Rossi, Alvaro Rabelo Junior, Nadine Clausell, José Francisco Kerr Saraiva, Lilian Soares da Costa, Maria Sanali Moura de Oliveira Paiva, Denilson Albuquerque, Humberto Villacorta Junior, João Carlos Rocha, Jean Paul Salembier, Filip Charlier, Laurence Gabriel, Gilles De Keulenaer, Josef Jandik, Eva Mandysova, Frantisek Padour, Petr Vojtisek, Jiri Vitovec, Lubor Golan, Lenka Hoskova, Dag Tichy, Josef Drazka, David Alan, Ivo Oral, Jiri Janousek, Bohuslav Cernosek, Francois Delahaye, Marc Ferriere, Michel Galinier, Jean Noël Trochu, Thierry Laperche, Zukai Chati, Pierre Gibelin, Nadir Benazza, Michel Martelet, Hermann Ochs, Harald Darius, Thomas Dengler, Raimund Erbel, Hans Figulla, Rainer Hambrecht, Gerd Hasenfuss, Michael Buerke, Robert Schwinger, Stephan Felix, Wolfgang von Scheidt, Stephan Holmer, Juergen Kolditz, Thomas Wichter, Dieter Horstkotte, Hans Neuser, Gerhard Hauf, Holger Vogelshberg, Luigi Tavazzi, Claudio Marabotti, Maurizio Porcu, Silvio Ricci, Tiziano Moccetti, Giovanni Ruggeri, Cristina Opasich, Franco Cosmi, Franco Masini, Pierfranco Terrosu, Vincenzo Cirrincione, Franco Cobelli, Ernesto Murena, Piergiuseppe Agostoni, Pantaleo Giannuzzi, Don Hertzberger, Anho Liem, Walther Jap, Eugene Buys, Frank Den Hartog, Pieter van der Burgh, Gerard Louis Bartels, Jan Wesdorp, Dirk Lok, Angela Maas, Rolf Veldkamp, Paul A.R. de Milliano, Torbjorn Omland, Christian Ostvold, Vernon Bonarjee, Anne Semb, Jacek Grzybowski, Wladyslav Sinkiewicz, Jerzy Kopaczewski, Malgorzata Krzciuk, Janusz Maciejewicz, Andrzej Malinski, Michal Ogorek, Wladyslaw Pluta, Ryszard Sciborski, Tomasz Waszyrowski, Grzegorz Opolski, Krystyna Jaworska, Piotr Ruszkowski, Fryderyk Prochaczek, Radu Capalneanu, Mircea Cinteza, Mihail Dan Datcu, Carmen Georgeta Fierbinteanu Braticevici, Dorel Nastase-Melicovici, Dan Ionescu, Cezar Eugen Macarie, Ioan Tiberiu Nanea, Mariana Radoi, Gabriel Petrisor Tatu-Chitoiu, Stefan Dragulescu, Carmen Ginghina, Félix Pèrez-Villa, Josè Maria Arizón, Jordi Mercé, Juan Delgado, Angel Grande, Pedro Montes, Francisco Ridocci, Manuel Vida, Thomas Kahan, Ulf Dahlström, Cecilia Linde, Gerhard Wikström, Bengt Johansson, Inger Hagerman, Ronnie Willenheimer, Bengt Widgren, John Cleland, Mirza Baig, Steven Lindsay, Jatinder Dhawan, Iain Square, Robert Bain, Anatoly Baranov, Nikolai Gratsiansky, Maria Sitnikova, Konstantin Zrazhevsky, Victor Kostenko, Vladimir Simanenkov, Olga Berkovich, Vagan Mkrtchuan, Mikhail Boyarkin, Raisa Stryuk, Vecheslav Mareev, Vladislav Novozhenov, Sergey Shustov, Lev Sorokin, Vladimir Zadionchenko, Nikita B. Perepech, Boris M. Tankhileitch, Gennady I. Storozhakov, Igor Bokarev, Natalia Sanina, A. Martynov, Sergey Chernov, Sidorienko, Marina Ballyusek

Research output: Contribution to journalArticle

152 Citations (Scopus)

Abstract

Background: Hospitalizations for worsening heart failure due to fluid overload (congestion) are common. Agents that treat congestion without causing electrolyte abnormalities or worsening renal function are needed. Tolvaptan is an oral vasopressin (V2) antagonist that decreases body weight and increases urine volume without inducing renal dysfunction or hypokalemia. The Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial is evaluating mortality, morbidity, and patient-assessed global clinical status in patients treated with tolvaptan compared with standard care. Methods and Results: Patients are eligible for inclusion if they have a reduced left ventricular ejection fraction and are hospitalized for worsening heart failure with evidence of systemic congestion. Patients are randomized 1:1 to tolvaptan 30 mg/day or matching placebo for a minimum of 60 days. Time to all-cause mortality and time to cardiovascular mortality or heart failure hospitalization are the coprimary end points. Patient-assessed global clinical status and quality of life are also evaluated. EVEREST will be continued until 1065 deaths occur. As of April 18, 2005, 2260 patients have been enrolled. Conclusion: Tolvaptan has been shown to reduce body weight in patients with worsening heart failure without inducing renal dysfunction or causing hypokalemia. The results of EVEREST will determine whether these effects translate into improved clinical outcomes.

Original languageEnglish (US)
Pages (from-to)260-269
Number of pages10
JournalJournal of Cardiac Failure
Volume11
Issue number4
DOIs
StatePublished - May 1 2005
Externally publishedYes

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Vasopressins
Heart Failure
Placebos
Outcome Assessment (Health Care)
Hypokalemia
Kidney
Mortality
Hospitalization
Body Weight
tolvaptan
Stroke Volume
Electrolytes
Quality of Life
Urine
Morbidity

Keywords

  • Clinical trials
  • Heart failure
  • Morbidity
  • Mortality
  • Vasopressin

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure : Outcome study with Tolvaptan (EVEREST). / Gheorghiade, Mihai; Orlandi, Cesare; Burnett, John C.; Demets, David; Grinfeld, Liliana; Maggioni, Aldo; Swedberg, Karl; Udelson, James E.; Zannad, Faiez; Zimmer, Christopher; Konstam, Marvin A.; Bahit, M. C.; Haass, M.; Carson, P. E.; Hauptman, P. J.; Metra, M.; Miller, A.; O’connor, C.; Oren, R. M.; Patten, R.; Pina, Ileana L.; Roth, Sherryn; Sackner-Bernstein, J.; Dargie, H.; Demets, D. L.; Dickstein, K.; Greenberg, B.; Goldstein, S.; Lerman, J.; Massie, B.; Pitt, B.; Ouyang, J.; Udelson, J.; Dieterich, H. A.; Capkova, Z.; Gadaleta, F.; Mule, M.; Pricipato, M. B.; Bilsker, Martin; Bishop, Timothy; Bresnahan, Dennis; Caskey, David; Chai, Andrew; Chung, Eugene; Mel Clark, Robert; Dec, William; Fishbein, Gary; Friedman, Scott; Ghali, Jalal; Gradman, Alan; Richards, David; Haugh, Connor; Hinchman, David; Ibrahim, Hassan; Imburgia, Michael; Roth, Eli; Sequeira, Rafael; Siegel, Robert; Stockwell, Phil; Vijay, Kris; Nanevicz, Tania; Weiss, Robert; Wright, Richard; Alexander, Jay; Altschul, Larry; Ashraf, Mohammad; Bergin, James; Brown, Chris; Capodilupo, Robert; Carhart, Robert; Carley, James; Clemson, Barry; Connelly, Terence; Corbelli, John; Doroghazi, Robert; Eichhorn, Eric; El-Shahawy, Mahfouz; Foley, John; Goldberg, Mark; Goldscher, David; Goldsmith, Steven; Hack, Terrence; Haskel, Ethan; Hassel, David; Hauptman, Paul; Rama, Pamela; Houck, Philip; Jansen, Donald; Jerome, Scott; Aude, Yamil; Joyce, David; Kachel, Richard; Kapadia, Shaival; Kipperman, Robert; Krasuski, Richard; Kronenberg, Marvin; Aduli, Farhad; Liston, Michael; Hodsen, James; McCriskin, James; McGrew, Frank; Shor, Robert; Munuswamy, Karan; Narayan, Puneet; Niazi, Imran; Dean Nukta, E.; O’brien, John; O’bryan, Joseph; Olivari, Maria Teresa; Ann Peberdy, Mary; Pirwitz, Mark Jeffrey; Prashad, Rakesh; Rubin, David; Safren, Jonathan; Saltzberg, Mitchell; Schuyler, Gregg; Roberts, Jonathan; Singh, Bramah; Sotolongo, Rodolfo; Stagaman, David; Stapleton, Dwight; Van Decker, William; Wilkins, Charles; El-Zaru, Mohamad; Kahn, Brian; Lash, Joseph; Banas, John; Banerjee, Supratim; Leonen, Marlo; Benza, Raymond; Colfer, Harry; Daher, Edouard; Fattal, Peter; Foster, Jack; Goodfield, Peter; Gupta, Dinesh; Hathaway, William; Haught, Herbert; Ishimori, Tetsuo; Iteld, Bruce; Kesselbrenner, Michael; Klapholz, Marc; McCullough, Peter; Cieszkowski, John; McMillan, Edward; Boyle, Andrew; Nathan, Mark; O’brien, Terrence; Felker, Gary; Oellerich, William; Pereira, Naveen; Sandberg, James; Schwarz, Ernst; Vicari, Ralph; Whittier, Frederick; Alvarez, Rene; Bank, Alan; Cobb, Fred; Cullinane, David; Dasgupta, Himadri; Heywood, J. T.; Krueger, Steve; Lowes, Brian; Rose, Jack; Sklar, Joel; Suh, J. Thomas; Vijay, Nampalli; Walsh, Mary; Chapman, Doug; Lachmann, Justine; Gordon, John; Kraus, David; Devries, Brent; Adams, Kirk; Bijou, Rachel; Elkayam, Uri; Fath, Kenneth; Ribner, Hillel; Schmedtje, John; Jackson, Bruce; Wight, Joseph; Miyamoto, Michael; Skopicki, Hal; Frantz, Robert; Kukin, Marrick; McBride, John; Tsao, Lana; Ryder, Richard; Koren, Michael; Taylor, Kenneth; Hebert, Kathy; Slawsky, Mara; Singh, Narendra; Brian, Christopher; Jafri, Syed; Smith, David; Monroe, Van Stephen; Greenspan, Mitchell; Silver, Marc; Wagoner, Lynne; Schneider, Ricky; Moskowitz, Robert; Yasin, Muhammad; Waldo, Douglas; Arik, Tali; Ducharme, Anique; Sussex, Bruce; Bakbak, Asaad; Borts, David; Chan, Y. K.; Charles, L. John; Giannetti, Nadia; Goode, J. E.; Klinke, W. Peter; Kornder, Jan; Giannoccaro, Peter; Kouz, Simon; Lenis, Jacques; Lepage, Serge; Moe, Gordon; Morris, Andrew; Pesant, Yves; Delgado, Diego; Huynh, Thao; Ma, Patrick; Halperin, Frank; Rebane, Thomas; Pandey, A. S.; Tronge, Jorge; Vulcano, Norberto; Bluguermann, Julio Jorge; Riccitelli, Miguel Angel; Chekherdemian, Sergio Martin; Colque, Roberto; Amuchastegui, Marcos; Perna, Eduardo Roque; Ballestrini, Aristóbulo Enrique; Posadas, Alejandro; Salvatti, Ana Maria; Girotti, Luis; Llois, Susana; Sultan, Monica; Grosso, Oscar; Estrada, Carlos; Salzberg, Simón Mario; Nul, Daniel; Guzmán, Luis; Halac, Marcelo; Perrone, Sergio; Liprandi, Alvaro Sosa; Barreto, Antonio Carlos Pereira; Blacher, Celso; Fernandes, Euler Roberto; Feitosa, Gilson Soares; Greque, Gilmar Valdir; Reis, Gilmar; Ribeiro, José Marcio; Maia, Lilia Nigro; Filho, Pedro Pimentel; Rassi, Salvador; Rossi, Paulo; Rabelo Junior, Alvaro; Clausell, Nadine; Saraiva, José Francisco Kerr; da Costa, Lilian Soares; de Oliveira Paiva, Maria Sanali Moura; Albuquerque, Denilson; Villacorta Junior, Humberto; Rocha, João Carlos; Salembier, Jean Paul; Charlier, Filip; Gabriel, Laurence; De Keulenaer, Gilles; Jandik, Josef; Mandysova, Eva; Padour, Frantisek; Vojtisek, Petr; Vitovec, Jiri; Golan, Lubor; Hoskova, Lenka; Tichy, Dag; Drazka, Josef; Alan, David; Oral, Ivo; Janousek, Jiri; Cernosek, Bohuslav; Delahaye, Francois; Ferriere, Marc; Galinier, Michel; Trochu, Jean Noël; Laperche, Thierry; Chati, Zukai; Gibelin, Pierre; Benazza, Nadir; Martelet, Michel; Ochs, Hermann; Darius, Harald; Dengler, Thomas; Erbel, Raimund; Figulla, Hans; Hambrecht, Rainer; Hasenfuss, Gerd; Buerke, Michael; Schwinger, Robert; Felix, Stephan; von Scheidt, Wolfgang; Holmer, Stephan; Kolditz, Juergen; Wichter, Thomas; Horstkotte, Dieter; Neuser, Hans; Hauf, Gerhard; Vogelshberg, Holger; Tavazzi, Luigi; Marabotti, Claudio; Porcu, Maurizio; Ricci, Silvio; Moccetti, Tiziano; Ruggeri, Giovanni; Opasich, Cristina; Cosmi, Franco; Masini, Franco; Terrosu, Pierfranco; Cirrincione, Vincenzo; Cobelli, Franco; Murena, Ernesto; Agostoni, Piergiuseppe; Giannuzzi, Pantaleo; Hertzberger, Don; Liem, Anho; Jap, Walther; Buys, Eugene; Den Hartog, Frank; van der Burgh, Pieter; Bartels, Gerard Louis; Wesdorp, Jan; Lok, Dirk; Maas, Angela; Veldkamp, Rolf; de Milliano, Paul A.R.; Omland, Torbjorn; Ostvold, Christian; Bonarjee, Vernon; Semb, Anne; Grzybowski, Jacek; Sinkiewicz, Wladyslav; Kopaczewski, Jerzy; Krzciuk, Malgorzata; Maciejewicz, Janusz; Malinski, Andrzej; Ogorek, Michal; Pluta, Wladyslaw; Sciborski, Ryszard; Waszyrowski, Tomasz; Opolski, Grzegorz; Jaworska, Krystyna; Ruszkowski, Piotr; Prochaczek, Fryderyk; Capalneanu, Radu; Cinteza, Mircea; Datcu, Mihail Dan; Braticevici, Carmen Georgeta Fierbinteanu; Nastase-Melicovici, Dorel; Ionescu, Dan; Macarie, Cezar Eugen; Nanea, Ioan Tiberiu; Radoi, Mariana; Tatu-Chitoiu, Gabriel Petrisor; Dragulescu, Stefan; Ginghina, Carmen; Pèrez-Villa, Félix; Arizón, Josè Maria; Mercé, Jordi; Delgado, Juan; Grande, Angel; Montes, Pedro; Ridocci, Francisco; Vida, Manuel; Kahan, Thomas; Dahlström, Ulf; Linde, Cecilia; Wikström, Gerhard; Johansson, Bengt; Hagerman, Inger; Willenheimer, Ronnie; Widgren, Bengt; Cleland, John; Baig, Mirza; Lindsay, Steven; Dhawan, Jatinder; Square, Iain; Bain, Robert; Baranov, Anatoly; Gratsiansky, Nikolai; Sitnikova, Maria; Zrazhevsky, Konstantin; Kostenko, Victor; Simanenkov, Vladimir; Berkovich, Olga; Mkrtchuan, Vagan; Boyarkin, Mikhail; Stryuk, Raisa; Mareev, Vecheslav; Novozhenov, Vladislav; Shustov, Sergey; Sorokin, Lev; Zadionchenko, Vladimir; Perepech, Nikita B.; Tankhileitch, Boris M.; Storozhakov, Gennady I.; Bokarev, Igor; Sanina, Natalia; Martynov, A.; Chernov, Sergey; Sidorienko; Ballyusek, Marina.

In: Journal of Cardiac Failure, Vol. 11, No. 4, 01.05.2005, p. 260-269.

Research output: Contribution to journalArticle

Gheorghiade, M, Orlandi, C, Burnett, JC, Demets, D, Grinfeld, L, Maggioni, A, Swedberg, K, Udelson, JE, Zannad, F, Zimmer, C, Konstam, MA, Bahit, MC, Haass, M, Carson, PE, Hauptman, PJ, Metra, M, Miller, A, O’connor, C, Oren, RM, Patten, R, Pina, IL, Roth, S, Sackner-Bernstein, J, Dargie, H, Demets, DL, Dickstein, K, Greenberg, B, Goldstein, S, Lerman, J, Massie, B, Pitt, B, Ouyang, J, Udelson, J, Dieterich, HA, Capkova, Z, Gadaleta, F, Mule, M, Pricipato, MB, Bilsker, M, Bishop, T, Bresnahan, D, Caskey, D, Chai, A, Chung, E, Mel Clark, R, Dec, W, Fishbein, G, Friedman, S, Ghali, J, Gradman, A, Richards, D, Haugh, C, Hinchman, D, Ibrahim, H, Imburgia, M, Roth, E, Sequeira, R, Siegel, R, Stockwell, P, Vijay, K, Nanevicz, T, Weiss, R, Wright, R, Alexander, J, Altschul, L, Ashraf, M, Bergin, J, Brown, C, Capodilupo, R, Carhart, R, Carley, J, Clemson, B, Connelly, T, Corbelli, J, Doroghazi, R, Eichhorn, E, El-Shahawy, M, Foley, J, Goldberg, M, Goldscher, D, Goldsmith, S, Hack, T, Haskel, E, Hassel, D, Hauptman, P, Rama, P, Houck, P, Jansen, D, Jerome, S, Aude, Y, Joyce, D, Kachel, R, Kapadia, S, Kipperman, R, Krasuski, R, Kronenberg, M, Aduli, F, Liston, M, Hodsen, J, McCriskin, J, McGrew, F, Shor, R, Munuswamy, K, Narayan, P, Niazi, I, Dean Nukta, E, O’brien, J, O’bryan, J, Olivari, MT, Ann Peberdy, M, Pirwitz, MJ, Prashad, R, Rubin, D, Safren, J, Saltzberg, M, Schuyler, G, Roberts, J, Singh, B, Sotolongo, R, Stagaman, D, Stapleton, D, Van Decker, W, Wilkins, C, El-Zaru, M, Kahn, B, Lash, J, Banas, J, Banerjee, S, Leonen, M, Benza, R, Colfer, H, Daher, E, Fattal, P, Foster, J, Goodfield, P, Gupta, D, Hathaway, W, Haught, H, Ishimori, T, Iteld, B, Kesselbrenner, M, Klapholz, M, McCullough, P, Cieszkowski, J, McMillan, E, Boyle, A, Nathan, M, O’brien, T, Felker, G, Oellerich, W, Pereira, N, Sandberg, J, Schwarz, E, Vicari, R, Whittier, F, Alvarez, R, Bank, A, Cobb, F, Cullinane, D, Dasgupta, H, Heywood, JT, Krueger, S, Lowes, B, Rose, J, Sklar, J, Suh, JT, Vijay, N, Walsh, M, Chapman, D, Lachmann, J, Gordon, J, Kraus, D, Devries, B, Adams, K, Bijou, R, Elkayam, U, Fath, K, Ribner, H, Schmedtje, J, Jackson, B, Wight, J, Miyamoto, M, Skopicki, H, Frantz, R, Kukin, M, McBride, J, Tsao, L, Ryder, R, Koren, M, Taylor, K, Hebert, K, Slawsky, M, Singh, N, Brian, C, Jafri, S, Smith, D, Monroe, VS, Greenspan, M, Silver, M, Wagoner, L, Schneider, R, Moskowitz, R, Yasin, M, Waldo, D, Arik, T, Ducharme, A, Sussex, B, Bakbak, A, Borts, D, Chan, YK, Charles, LJ, Giannetti, N, Goode, JE, Klinke, WP, Kornder, J, Giannoccaro, P, Kouz, S, Lenis, J, Lepage, S, Moe, G, Morris, A, Pesant, Y, Delgado, D, Huynh, T, Ma, P, Halperin, F, Rebane, T, Pandey, AS, Tronge, J, Vulcano, N, Bluguermann, JJ, Riccitelli, MA, Chekherdemian, SM, Colque, R, Amuchastegui, M, Perna, ER, Ballestrini, AE, Posadas, A, Salvatti, AM, Girotti, L, Llois, S, Sultan, M, Grosso, O, Estrada, C, Salzberg, SM, Nul, D, Guzmán, L, Halac, M, Perrone, S, Liprandi, AS, Barreto, ACP, Blacher, C, Fernandes, ER, Feitosa, GS, Greque, GV, Reis, G, Ribeiro, JM, Maia, LN, Filho, PP, Rassi, S, Rossi, P, Rabelo Junior, A, Clausell, N, Saraiva, JFK, da Costa, LS, de Oliveira Paiva, MSM, Albuquerque, D, Villacorta Junior, H, Rocha, JC, Salembier, JP, Charlier, F, Gabriel, L, De Keulenaer, G, Jandik, J, Mandysova, E, Padour, F, Vojtisek, P, Vitovec, J, Golan, L, Hoskova, L, Tichy, D, Drazka, J, Alan, D, Oral, I, Janousek, J, Cernosek, B, Delahaye, F, Ferriere, M, Galinier, M, Trochu, JN, Laperche, T, Chati, Z, Gibelin, P, Benazza, N, Martelet, M, Ochs, H, Darius, H, Dengler, T, Erbel, R, Figulla, H, Hambrecht, R, Hasenfuss, G, Buerke, M, Schwinger, R, Felix, S, von Scheidt, W, Holmer, S, Kolditz, J, Wichter, T, Horstkotte, D, Neuser, H, Hauf, G, Vogelshberg, H, Tavazzi, L, Marabotti, C, Porcu, M, Ricci, S, Moccetti, T, Ruggeri, G, Opasich, C, Cosmi, F, Masini, F, Terrosu, P, Cirrincione, V, Cobelli, F, Murena, E, Agostoni, P, Giannuzzi, P, Hertzberger, D, Liem, A, Jap, W, Buys, E, Den Hartog, F, van der Burgh, P, Bartels, GL, Wesdorp, J, Lok, D, Maas, A, Veldkamp, R, de Milliano, PAR, Omland, T, Ostvold, C, Bonarjee, V, Semb, A, Grzybowski, J, Sinkiewicz, W, Kopaczewski, J, Krzciuk, M, Maciejewicz, J, Malinski, A, Ogorek, M, Pluta, W, Sciborski, R, Waszyrowski, T, Opolski, G, Jaworska, K, Ruszkowski, P, Prochaczek, F, Capalneanu, R, Cinteza, M, Datcu, MD, Braticevici, CGF, Nastase-Melicovici, D, Ionescu, D, Macarie, CE, Nanea, IT, Radoi, M, Tatu-Chitoiu, GP, Dragulescu, S, Ginghina, C, Pèrez-Villa, F, Arizón, JM, Mercé, J, Delgado, J, Grande, A, Montes, P, Ridocci, F, Vida, M, Kahan, T, Dahlström, U, Linde, C, Wikström, G, Johansson, B, Hagerman, I, Willenheimer, R, Widgren, B, Cleland, J, Baig, M, Lindsay, S, Dhawan, J, Square, I, Bain, R, Baranov, A, Gratsiansky, N, Sitnikova, M, Zrazhevsky, K, Kostenko, V, Simanenkov, V, Berkovich, O, Mkrtchuan, V, Boyarkin, M, Stryuk, R, Mareev, V, Novozhenov, V, Shustov, S, Sorokin, L, Zadionchenko, V, Perepech, NB, Tankhileitch, BM, Storozhakov, GI, Bokarev, I, Sanina, N, Martynov, A, Chernov, S, Sidorienko & Ballyusek, M 2005, 'Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure: Outcome study with Tolvaptan (EVEREST)', Journal of Cardiac Failure, vol. 11, no. 4, pp. 260-269. https://doi.org/10.1016/j.cardfail.2005.03.009
Gheorghiade, Mihai ; Orlandi, Cesare ; Burnett, John C. ; Demets, David ; Grinfeld, Liliana ; Maggioni, Aldo ; Swedberg, Karl ; Udelson, James E. ; Zannad, Faiez ; Zimmer, Christopher ; Konstam, Marvin A. ; Bahit, M. C. ; Haass, M. ; Carson, P. E. ; Hauptman, P. J. ; Metra, M. ; Miller, A. ; O’connor, C. ; Oren, R. M. ; Patten, R. ; Pina, Ileana L. ; Roth, Sherryn ; Sackner-Bernstein, J. ; Dargie, H. ; Demets, D. L. ; Dickstein, K. ; Greenberg, B. ; Goldstein, S. ; Lerman, J. ; Massie, B. ; Pitt, B. ; Ouyang, J. ; Udelson, J. ; Dieterich, H. A. ; Capkova, Z. ; Gadaleta, F. ; Mule, M. ; Pricipato, M. B. ; Bilsker, Martin ; Bishop, Timothy ; Bresnahan, Dennis ; Caskey, David ; Chai, Andrew ; Chung, Eugene ; Mel Clark, Robert ; Dec, William ; Fishbein, Gary ; Friedman, Scott ; Ghali, Jalal ; Gradman, Alan ; Richards, David ; Haugh, Connor ; Hinchman, David ; Ibrahim, Hassan ; Imburgia, Michael ; Roth, Eli ; Sequeira, Rafael ; Siegel, Robert ; Stockwell, Phil ; Vijay, Kris ; Nanevicz, Tania ; Weiss, Robert ; Wright, Richard ; Alexander, Jay ; Altschul, Larry ; Ashraf, Mohammad ; Bergin, James ; Brown, Chris ; Capodilupo, Robert ; Carhart, Robert ; Carley, James ; Clemson, Barry ; Connelly, Terence ; Corbelli, John ; Doroghazi, Robert ; Eichhorn, Eric ; El-Shahawy, Mahfouz ; Foley, John ; Goldberg, Mark ; Goldscher, David ; Goldsmith, Steven ; Hack, Terrence ; Haskel, Ethan ; Hassel, David ; Hauptman, Paul ; Rama, Pamela ; Houck, Philip ; Jansen, Donald ; Jerome, Scott ; Aude, Yamil ; Joyce, David ; Kachel, Richard ; Kapadia, Shaival ; Kipperman, Robert ; Krasuski, Richard ; Kronenberg, Marvin ; Aduli, Farhad ; Liston, Michael ; Hodsen, James ; McCriskin, James ; McGrew, Frank ; Shor, Robert ; Munuswamy, Karan ; Narayan, Puneet ; Niazi, Imran ; Dean Nukta, E. ; O’brien, John ; O’bryan, Joseph ; Olivari, Maria Teresa ; Ann Peberdy, Mary ; Pirwitz, Mark Jeffrey ; Prashad, Rakesh ; Rubin, David ; Safren, Jonathan ; Saltzberg, Mitchell ; Schuyler, Gregg ; Roberts, Jonathan ; Singh, Bramah ; Sotolongo, Rodolfo ; Stagaman, David ; Stapleton, Dwight ; Van Decker, William ; Wilkins, Charles ; El-Zaru, Mohamad ; Kahn, Brian ; Lash, Joseph ; Banas, John ; Banerjee, Supratim ; Leonen, Marlo ; Benza, Raymond ; Colfer, Harry ; Daher, Edouard ; Fattal, Peter ; Foster, Jack ; Goodfield, Peter ; Gupta, Dinesh ; Hathaway, William ; Haught, Herbert ; Ishimori, Tetsuo ; Iteld, Bruce ; Kesselbrenner, Michael ; Klapholz, Marc ; McCullough, Peter ; Cieszkowski, John ; McMillan, Edward ; Boyle, Andrew ; Nathan, Mark ; O’brien, Terrence ; Felker, Gary ; Oellerich, William ; Pereira, Naveen ; Sandberg, James ; Schwarz, Ernst ; Vicari, Ralph ; Whittier, Frederick ; Alvarez, Rene ; Bank, Alan ; Cobb, Fred ; Cullinane, David ; Dasgupta, Himadri ; Heywood, J. T. ; Krueger, Steve ; Lowes, Brian ; Rose, Jack ; Sklar, Joel ; Suh, J. Thomas ; Vijay, Nampalli ; Walsh, Mary ; Chapman, Doug ; Lachmann, Justine ; Gordon, John ; Kraus, David ; Devries, Brent ; Adams, Kirk ; Bijou, Rachel ; Elkayam, Uri ; Fath, Kenneth ; Ribner, Hillel ; Schmedtje, John ; Jackson, Bruce ; Wight, Joseph ; Miyamoto, Michael ; Skopicki, Hal ; Frantz, Robert ; Kukin, Marrick ; McBride, John ; Tsao, Lana ; Ryder, Richard ; Koren, Michael ; Taylor, Kenneth ; Hebert, Kathy ; Slawsky, Mara ; Singh, Narendra ; Brian, Christopher ; Jafri, Syed ; Smith, David ; Monroe, Van Stephen ; Greenspan, Mitchell ; Silver, Marc ; Wagoner, Lynne ; Schneider, Ricky ; Moskowitz, Robert ; Yasin, Muhammad ; Waldo, Douglas ; Arik, Tali ; Ducharme, Anique ; Sussex, Bruce ; Bakbak, Asaad ; Borts, David ; Chan, Y. K. ; Charles, L. John ; Giannetti, Nadia ; Goode, J. E. ; Klinke, W. Peter ; Kornder, Jan ; Giannoccaro, Peter ; Kouz, Simon ; Lenis, Jacques ; Lepage, Serge ; Moe, Gordon ; Morris, Andrew ; Pesant, Yves ; Delgado, Diego ; Huynh, Thao ; Ma, Patrick ; Halperin, Frank ; Rebane, Thomas ; Pandey, A. S. ; Tronge, Jorge ; Vulcano, Norberto ; Bluguermann, Julio Jorge ; Riccitelli, Miguel Angel ; Chekherdemian, Sergio Martin ; Colque, Roberto ; Amuchastegui, Marcos ; Perna, Eduardo Roque ; Ballestrini, Aristóbulo Enrique ; Posadas, Alejandro ; Salvatti, Ana Maria ; Girotti, Luis ; Llois, Susana ; Sultan, Monica ; Grosso, Oscar ; Estrada, Carlos ; Salzberg, Simón Mario ; Nul, Daniel ; Guzmán, Luis ; Halac, Marcelo ; Perrone, Sergio ; Liprandi, Alvaro Sosa ; Barreto, Antonio Carlos Pereira ; Blacher, Celso ; Fernandes, Euler Roberto ; Feitosa, Gilson Soares ; Greque, Gilmar Valdir ; Reis, Gilmar ; Ribeiro, José Marcio ; Maia, Lilia Nigro ; Filho, Pedro Pimentel ; Rassi, Salvador ; Rossi, Paulo ; Rabelo Junior, Alvaro ; Clausell, Nadine ; Saraiva, José Francisco Kerr ; da Costa, Lilian Soares ; de Oliveira Paiva, Maria Sanali Moura ; Albuquerque, Denilson ; Villacorta Junior, Humberto ; Rocha, João Carlos ; Salembier, Jean Paul ; Charlier, Filip ; Gabriel, Laurence ; De Keulenaer, Gilles ; Jandik, Josef ; Mandysova, Eva ; Padour, Frantisek ; Vojtisek, Petr ; Vitovec, Jiri ; Golan, Lubor ; Hoskova, Lenka ; Tichy, Dag ; Drazka, Josef ; Alan, David ; Oral, Ivo ; Janousek, Jiri ; Cernosek, Bohuslav ; Delahaye, Francois ; Ferriere, Marc ; Galinier, Michel ; Trochu, Jean Noël ; Laperche, Thierry ; Chati, Zukai ; Gibelin, Pierre ; Benazza, Nadir ; Martelet, Michel ; Ochs, Hermann ; Darius, Harald ; Dengler, Thomas ; Erbel, Raimund ; Figulla, Hans ; Hambrecht, Rainer ; Hasenfuss, Gerd ; Buerke, Michael ; Schwinger, Robert ; Felix, Stephan ; von Scheidt, Wolfgang ; Holmer, Stephan ; Kolditz, Juergen ; Wichter, Thomas ; Horstkotte, Dieter ; Neuser, Hans ; Hauf, Gerhard ; Vogelshberg, Holger ; Tavazzi, Luigi ; Marabotti, Claudio ; Porcu, Maurizio ; Ricci, Silvio ; Moccetti, Tiziano ; Ruggeri, Giovanni ; Opasich, Cristina ; Cosmi, Franco ; Masini, Franco ; Terrosu, Pierfranco ; Cirrincione, Vincenzo ; Cobelli, Franco ; Murena, Ernesto ; Agostoni, Piergiuseppe ; Giannuzzi, Pantaleo ; Hertzberger, Don ; Liem, Anho ; Jap, Walther ; Buys, Eugene ; Den Hartog, Frank ; van der Burgh, Pieter ; Bartels, Gerard Louis ; Wesdorp, Jan ; Lok, Dirk ; Maas, Angela ; Veldkamp, Rolf ; de Milliano, Paul A.R. ; Omland, Torbjorn ; Ostvold, Christian ; Bonarjee, Vernon ; Semb, Anne ; Grzybowski, Jacek ; Sinkiewicz, Wladyslav ; Kopaczewski, Jerzy ; Krzciuk, Malgorzata ; Maciejewicz, Janusz ; Malinski, Andrzej ; Ogorek, Michal ; Pluta, Wladyslaw ; Sciborski, Ryszard ; Waszyrowski, Tomasz ; Opolski, Grzegorz ; Jaworska, Krystyna ; Ruszkowski, Piotr ; Prochaczek, Fryderyk ; Capalneanu, Radu ; Cinteza, Mircea ; Datcu, Mihail Dan ; Braticevici, Carmen Georgeta Fierbinteanu ; Nastase-Melicovici, Dorel ; Ionescu, Dan ; Macarie, Cezar Eugen ; Nanea, Ioan Tiberiu ; Radoi, Mariana ; Tatu-Chitoiu, Gabriel Petrisor ; Dragulescu, Stefan ; Ginghina, Carmen ; Pèrez-Villa, Félix ; Arizón, Josè Maria ; Mercé, Jordi ; Delgado, Juan ; Grande, Angel ; Montes, Pedro ; Ridocci, Francisco ; Vida, Manuel ; Kahan, Thomas ; Dahlström, Ulf ; Linde, Cecilia ; Wikström, Gerhard ; Johansson, Bengt ; Hagerman, Inger ; Willenheimer, Ronnie ; Widgren, Bengt ; Cleland, John ; Baig, Mirza ; Lindsay, Steven ; Dhawan, Jatinder ; Square, Iain ; Bain, Robert ; Baranov, Anatoly ; Gratsiansky, Nikolai ; Sitnikova, Maria ; Zrazhevsky, Konstantin ; Kostenko, Victor ; Simanenkov, Vladimir ; Berkovich, Olga ; Mkrtchuan, Vagan ; Boyarkin, Mikhail ; Stryuk, Raisa ; Mareev, Vecheslav ; Novozhenov, Vladislav ; Shustov, Sergey ; Sorokin, Lev ; Zadionchenko, Vladimir ; Perepech, Nikita B. ; Tankhileitch, Boris M. ; Storozhakov, Gennady I. ; Bokarev, Igor ; Sanina, Natalia ; Martynov, A. ; Chernov, Sergey ; Sidorienko ; Ballyusek, Marina. / Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure : Outcome study with Tolvaptan (EVEREST). In: Journal of Cardiac Failure. 2005 ; Vol. 11, No. 4. pp. 260-269.
@article{9373810b9a764d67a91df8af1c77c105,
title = "Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure: Outcome study with Tolvaptan (EVEREST)",
abstract = "Background: Hospitalizations for worsening heart failure due to fluid overload (congestion) are common. Agents that treat congestion without causing electrolyte abnormalities or worsening renal function are needed. Tolvaptan is an oral vasopressin (V2) antagonist that decreases body weight and increases urine volume without inducing renal dysfunction or hypokalemia. The Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial is evaluating mortality, morbidity, and patient-assessed global clinical status in patients treated with tolvaptan compared with standard care. Methods and Results: Patients are eligible for inclusion if they have a reduced left ventricular ejection fraction and are hospitalized for worsening heart failure with evidence of systemic congestion. Patients are randomized 1:1 to tolvaptan 30 mg/day or matching placebo for a minimum of 60 days. Time to all-cause mortality and time to cardiovascular mortality or heart failure hospitalization are the coprimary end points. Patient-assessed global clinical status and quality of life are also evaluated. EVEREST will be continued until 1065 deaths occur. As of April 18, 2005, 2260 patients have been enrolled. Conclusion: Tolvaptan has been shown to reduce body weight in patients with worsening heart failure without inducing renal dysfunction or causing hypokalemia. The results of EVEREST will determine whether these effects translate into improved clinical outcomes.",
keywords = "Clinical trials, Heart failure, Morbidity, Mortality, Vasopressin",
author = "Mihai Gheorghiade and Cesare Orlandi and Burnett, {John C.} and David Demets and Liliana Grinfeld and Aldo Maggioni and Karl Swedberg and Udelson, {James E.} and Faiez Zannad and Christopher Zimmer and Konstam, {Marvin A.} and Bahit, {M. C.} and M. Haass and Carson, {P. E.} and Hauptman, {P. J.} and M. Metra and A. Miller and C. O’connor and Oren, {R. M.} and R. Patten and Pina, {Ileana L.} and Sherryn Roth and J. Sackner-Bernstein and H. Dargie and Demets, {D. L.} and K. Dickstein and B. Greenberg and S. Goldstein and J. Lerman and B. Massie and B. Pitt and J. Ouyang and J. Udelson and Dieterich, {H. A.} and Z. Capkova and F. Gadaleta and M. Mule and Pricipato, {M. B.} and Martin Bilsker and Timothy Bishop and Dennis Bresnahan and David Caskey and Andrew Chai and Eugene Chung and {Mel Clark}, Robert and William Dec and Gary Fishbein and Scott Friedman and Jalal Ghali and Alan Gradman and David Richards and Connor Haugh and David Hinchman and Hassan Ibrahim and Michael Imburgia and Eli Roth and Rafael Sequeira and Robert Siegel and Phil Stockwell and Kris Vijay and Tania Nanevicz and Robert Weiss and Richard Wright and Jay Alexander and Larry Altschul and Mohammad Ashraf and James Bergin and Chris Brown and Robert Capodilupo and Robert Carhart and James Carley and Barry Clemson and Terence Connelly and John Corbelli and Robert Doroghazi and Eric Eichhorn and Mahfouz El-Shahawy and John Foley and Mark Goldberg and David Goldscher and Steven Goldsmith and Terrence Hack and Ethan Haskel and David Hassel and Paul Hauptman and Pamela Rama and Philip Houck and Donald Jansen and Scott Jerome and Yamil Aude and David Joyce and Richard Kachel and Shaival Kapadia and Robert Kipperman and Richard Krasuski and Marvin Kronenberg and Farhad Aduli and Michael Liston and James Hodsen and James McCriskin and Frank McGrew and Robert Shor and Karan Munuswamy and Puneet Narayan and Imran Niazi and {Dean Nukta}, E. and John O’brien and Joseph O’bryan and Olivari, {Maria Teresa} and {Ann Peberdy}, Mary and Pirwitz, {Mark Jeffrey} and Rakesh Prashad and David Rubin and Jonathan Safren and Mitchell Saltzberg and Gregg Schuyler and Jonathan Roberts and Bramah Singh and Rodolfo Sotolongo and David Stagaman and Dwight Stapleton and {Van Decker}, William and Charles Wilkins and Mohamad El-Zaru and Brian Kahn and Joseph Lash and John Banas and Supratim Banerjee and Marlo Leonen and Raymond Benza and Harry Colfer and Edouard Daher and Peter Fattal and Jack Foster and Peter Goodfield and Dinesh Gupta and William Hathaway and Herbert Haught and Tetsuo Ishimori and Bruce Iteld and Michael Kesselbrenner and Marc Klapholz and Peter McCullough and John Cieszkowski and Edward McMillan and Andrew Boyle and Mark Nathan and Terrence O’brien and Gary Felker and William Oellerich and Naveen Pereira and James Sandberg and Ernst Schwarz and Ralph Vicari and Frederick Whittier and Rene Alvarez and Alan Bank and Fred Cobb and David Cullinane and Himadri Dasgupta and Heywood, {J. T.} and Steve Krueger and Brian Lowes and Jack Rose and Joel Sklar and Suh, {J. Thomas} and Nampalli Vijay and Mary Walsh and Doug Chapman and Justine Lachmann and John Gordon and David Kraus and Brent Devries and Kirk Adams and Rachel Bijou and Uri Elkayam and Kenneth Fath and Hillel Ribner and John Schmedtje and Bruce Jackson and Joseph Wight and Michael Miyamoto and Hal Skopicki and Robert Frantz and Marrick Kukin and John McBride and Lana Tsao and Richard Ryder and Michael Koren and Kenneth Taylor and Kathy Hebert and Mara Slawsky and Narendra Singh and Christopher Brian and Syed Jafri and David Smith and Monroe, {Van Stephen} and Mitchell Greenspan and Marc Silver and Lynne Wagoner and Ricky Schneider and Robert Moskowitz and Muhammad Yasin and Douglas Waldo and Tali Arik and Anique Ducharme and Bruce Sussex and Asaad Bakbak and David Borts and Chan, {Y. K.} and Charles, {L. John} and Nadia Giannetti and Goode, {J. E.} and Klinke, {W. Peter} and Jan Kornder and Peter Giannoccaro and Simon Kouz and Jacques Lenis and Serge Lepage and Gordon Moe and Andrew Morris and Yves Pesant and Diego Delgado and Thao Huynh and Patrick Ma and Frank Halperin and Thomas Rebane and Pandey, {A. S.} and Jorge Tronge and Norberto Vulcano and Bluguermann, {Julio Jorge} and Riccitelli, {Miguel Angel} and Chekherdemian, {Sergio Martin} and Roberto Colque and Marcos Amuchastegui and Perna, {Eduardo Roque} and Ballestrini, {Arist{\'o}bulo Enrique} and Alejandro Posadas and Salvatti, {Ana Maria} and Luis Girotti and Susana Llois and Monica Sultan and Oscar Grosso and Carlos Estrada and Salzberg, {Sim{\'o}n Mario} and Daniel Nul and Luis Guzm{\'a}n and Marcelo Halac and Sergio Perrone and Liprandi, {Alvaro Sosa} and Barreto, {Antonio Carlos Pereira} and Celso Blacher and Fernandes, {Euler Roberto} and Feitosa, {Gilson Soares} and Greque, {Gilmar Valdir} and Gilmar Reis and Ribeiro, {Jos{\'e} Marcio} and Maia, {Lilia Nigro} and Filho, {Pedro Pimentel} and Salvador Rassi and Paulo Rossi and {Rabelo Junior}, Alvaro and Nadine Clausell and Saraiva, {Jos{\'e} Francisco Kerr} and {da Costa}, {Lilian Soares} and {de Oliveira Paiva}, {Maria Sanali Moura} and Denilson Albuquerque and {Villacorta Junior}, Humberto and Rocha, {Jo{\~a}o Carlos} and Salembier, {Jean Paul} and Filip Charlier and Laurence Gabriel and {De Keulenaer}, Gilles and Josef Jandik and Eva Mandysova and Frantisek Padour and Petr Vojtisek and Jiri Vitovec and Lubor Golan and Lenka Hoskova and Dag Tichy and Josef Drazka and David Alan and Ivo Oral and Jiri Janousek and Bohuslav Cernosek and Francois Delahaye and Marc Ferriere and Michel Galinier and Trochu, {Jean No{\"e}l} and Thierry Laperche and Zukai Chati and Pierre Gibelin and Nadir Benazza and Michel Martelet and Hermann Ochs and Harald Darius and Thomas Dengler and Raimund Erbel and Hans Figulla and Rainer Hambrecht and Gerd Hasenfuss and Michael Buerke and Robert Schwinger and Stephan Felix and {von Scheidt}, Wolfgang and Stephan Holmer and Juergen Kolditz and Thomas Wichter and Dieter Horstkotte and Hans Neuser and Gerhard Hauf and Holger Vogelshberg and Luigi Tavazzi and Claudio Marabotti and Maurizio Porcu and Silvio Ricci and Tiziano Moccetti and Giovanni Ruggeri and Cristina Opasich and Franco Cosmi and Franco Masini and Pierfranco Terrosu and Vincenzo Cirrincione and Franco Cobelli and Ernesto Murena and Piergiuseppe Agostoni and Pantaleo Giannuzzi and Don Hertzberger and Anho Liem and Walther Jap and Eugene Buys and {Den Hartog}, Frank and {van der Burgh}, Pieter and Bartels, {Gerard Louis} and Jan Wesdorp and Dirk Lok and Angela Maas and Rolf Veldkamp and {de Milliano}, {Paul A.R.} and Torbjorn Omland and Christian Ostvold and Vernon Bonarjee and Anne Semb and Jacek Grzybowski and Wladyslav Sinkiewicz and Jerzy Kopaczewski and Malgorzata Krzciuk and Janusz Maciejewicz and Andrzej Malinski and Michal Ogorek and Wladyslaw Pluta and Ryszard Sciborski and Tomasz Waszyrowski and Grzegorz Opolski and Krystyna Jaworska and Piotr Ruszkowski and Fryderyk Prochaczek and Radu Capalneanu and Mircea Cinteza and Datcu, {Mihail Dan} and Braticevici, {Carmen Georgeta Fierbinteanu} and Dorel Nastase-Melicovici and Dan Ionescu and Macarie, {Cezar Eugen} and Nanea, {Ioan Tiberiu} and Mariana Radoi and Tatu-Chitoiu, {Gabriel Petrisor} and Stefan Dragulescu and Carmen Ginghina and F{\'e}lix P{\`e}rez-Villa and Ariz{\'o}n, {Jos{\`e} Maria} and Jordi Merc{\'e} and Juan Delgado and Angel Grande and Pedro Montes and Francisco Ridocci and Manuel Vida and Thomas Kahan and Ulf Dahlstr{\"o}m and Cecilia Linde and Gerhard Wikstr{\"o}m and Bengt Johansson and Inger Hagerman and Ronnie Willenheimer and Bengt Widgren and John Cleland and Mirza Baig and Steven Lindsay and Jatinder Dhawan and Iain Square and Robert Bain and Anatoly Baranov and Nikolai Gratsiansky and Maria Sitnikova and Konstantin Zrazhevsky and Victor Kostenko and Vladimir Simanenkov and Olga Berkovich and Vagan Mkrtchuan and Mikhail Boyarkin and Raisa Stryuk and Vecheslav Mareev and Vladislav Novozhenov and Sergey Shustov and Lev Sorokin and Vladimir Zadionchenko and Perepech, {Nikita B.} and Tankhileitch, {Boris M.} and Storozhakov, {Gennady I.} and Igor Bokarev and Natalia Sanina and A. Martynov and Sergey Chernov and Sidorienko and Marina Ballyusek",
year = "2005",
month = "5",
day = "1",
doi = "10.1016/j.cardfail.2005.03.009",
language = "English (US)",
volume = "11",
pages = "260--269",
journal = "Journal of Cardiac Failure",
issn = "1071-9164",
publisher = "Churchill Livingstone",
number = "4",

}

TY - JOUR

T1 - Rationale and design of the multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy of vasopressin antagonism in heart failure

T2 - Outcome study with Tolvaptan (EVEREST)

AU - Gheorghiade, Mihai

AU - Orlandi, Cesare

AU - Burnett, John C.

AU - Demets, David

AU - Grinfeld, Liliana

AU - Maggioni, Aldo

AU - Swedberg, Karl

AU - Udelson, James E.

AU - Zannad, Faiez

AU - Zimmer, Christopher

AU - Konstam, Marvin A.

AU - Bahit, M. C.

AU - Haass, M.

AU - Carson, P. E.

AU - Hauptman, P. J.

AU - Metra, M.

AU - Miller, A.

AU - O’connor, C.

AU - Oren, R. M.

AU - Patten, R.

AU - Pina, Ileana L.

AU - Roth, Sherryn

AU - Sackner-Bernstein, J.

AU - Dargie, H.

AU - Demets, D. L.

AU - Dickstein, K.

AU - Greenberg, B.

AU - Goldstein, S.

AU - Lerman, J.

AU - Massie, B.

AU - Pitt, B.

AU - Ouyang, J.

AU - Udelson, J.

AU - Dieterich, H. A.

AU - Capkova, Z.

AU - Gadaleta, F.

AU - Mule, M.

AU - Pricipato, M. B.

AU - Bilsker, Martin

AU - Bishop, Timothy

AU - Bresnahan, Dennis

AU - Caskey, David

AU - Chai, Andrew

AU - Chung, Eugene

AU - Mel Clark, Robert

AU - Dec, William

AU - Fishbein, Gary

AU - Friedman, Scott

AU - Ghali, Jalal

AU - Gradman, Alan

AU - Richards, David

AU - Haugh, Connor

AU - Hinchman, David

AU - Ibrahim, Hassan

AU - Imburgia, Michael

AU - Roth, Eli

AU - Sequeira, Rafael

AU - Siegel, Robert

AU - Stockwell, Phil

AU - Vijay, Kris

AU - Nanevicz, Tania

AU - Weiss, Robert

AU - Wright, Richard

AU - Alexander, Jay

AU - Altschul, Larry

AU - Ashraf, Mohammad

AU - Bergin, James

AU - Brown, Chris

AU - Capodilupo, Robert

AU - Carhart, Robert

AU - Carley, James

AU - Clemson, Barry

AU - Connelly, Terence

AU - Corbelli, John

AU - Doroghazi, Robert

AU - Eichhorn, Eric

AU - El-Shahawy, Mahfouz

AU - Foley, John

AU - Goldberg, Mark

AU - Goldscher, David

AU - Goldsmith, Steven

AU - Hack, Terrence

AU - Haskel, Ethan

AU - Hassel, David

AU - Hauptman, Paul

AU - Rama, Pamela

AU - Houck, Philip

AU - Jansen, Donald

AU - Jerome, Scott

AU - Aude, Yamil

AU - Joyce, David

AU - Kachel, Richard

AU - Kapadia, Shaival

AU - Kipperman, Robert

AU - Krasuski, Richard

AU - Kronenberg, Marvin

AU - Aduli, Farhad

AU - Liston, Michael

AU - Hodsen, James

AU - McCriskin, James

AU - McGrew, Frank

AU - Shor, Robert

AU - Munuswamy, Karan

AU - Narayan, Puneet

AU - Niazi, Imran

AU - Dean Nukta, E.

AU - O’brien, John

AU - O’bryan, Joseph

AU - Olivari, Maria Teresa

AU - Ann Peberdy, Mary

AU - Pirwitz, Mark Jeffrey

AU - Prashad, Rakesh

AU - Rubin, David

AU - Safren, Jonathan

AU - Saltzberg, Mitchell

AU - Schuyler, Gregg

AU - Roberts, Jonathan

AU - Singh, Bramah

AU - Sotolongo, Rodolfo

AU - Stagaman, David

AU - Stapleton, Dwight

AU - Van Decker, William

AU - Wilkins, Charles

AU - El-Zaru, Mohamad

AU - Kahn, Brian

AU - Lash, Joseph

AU - Banas, John

AU - Banerjee, Supratim

AU - Leonen, Marlo

AU - Benza, Raymond

AU - Colfer, Harry

AU - Daher, Edouard

AU - Fattal, Peter

AU - Foster, Jack

AU - Goodfield, Peter

AU - Gupta, Dinesh

AU - Hathaway, William

AU - Haught, Herbert

AU - Ishimori, Tetsuo

AU - Iteld, Bruce

AU - Kesselbrenner, Michael

AU - Klapholz, Marc

AU - McCullough, Peter

AU - Cieszkowski, John

AU - McMillan, Edward

AU - Boyle, Andrew

AU - Nathan, Mark

AU - O’brien, Terrence

AU - Felker, Gary

AU - Oellerich, William

AU - Pereira, Naveen

AU - Sandberg, James

AU - Schwarz, Ernst

AU - Vicari, Ralph

AU - Whittier, Frederick

AU - Alvarez, Rene

AU - Bank, Alan

AU - Cobb, Fred

AU - Cullinane, David

AU - Dasgupta, Himadri

AU - Heywood, J. T.

AU - Krueger, Steve

AU - Lowes, Brian

AU - Rose, Jack

AU - Sklar, Joel

AU - Suh, J. Thomas

AU - Vijay, Nampalli

AU - Walsh, Mary

AU - Chapman, Doug

AU - Lachmann, Justine

AU - Gordon, John

AU - Kraus, David

AU - Devries, Brent

AU - Adams, Kirk

AU - Bijou, Rachel

AU - Elkayam, Uri

AU - Fath, Kenneth

AU - Ribner, Hillel

AU - Schmedtje, John

AU - Jackson, Bruce

AU - Wight, Joseph

AU - Miyamoto, Michael

AU - Skopicki, Hal

AU - Frantz, Robert

AU - Kukin, Marrick

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AU - Pèrez-Villa, Félix

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AU - Johansson, Bengt

AU - Hagerman, Inger

AU - Willenheimer, Ronnie

AU - Widgren, Bengt

AU - Cleland, John

AU - Baig, Mirza

AU - Lindsay, Steven

AU - Dhawan, Jatinder

AU - Square, Iain

AU - Bain, Robert

AU - Baranov, Anatoly

AU - Gratsiansky, Nikolai

AU - Sitnikova, Maria

AU - Zrazhevsky, Konstantin

AU - Kostenko, Victor

AU - Simanenkov, Vladimir

AU - Berkovich, Olga

AU - Mkrtchuan, Vagan

AU - Boyarkin, Mikhail

AU - Stryuk, Raisa

AU - Mareev, Vecheslav

AU - Novozhenov, Vladislav

AU - Shustov, Sergey

AU - Sorokin, Lev

AU - Zadionchenko, Vladimir

AU - Perepech, Nikita B.

AU - Tankhileitch, Boris M.

AU - Storozhakov, Gennady I.

AU - Bokarev, Igor

AU - Sanina, Natalia

AU - Martynov, A.

AU - Chernov, Sergey

AU - Sidorienko,

AU - Ballyusek, Marina

PY - 2005/5/1

Y1 - 2005/5/1

N2 - Background: Hospitalizations for worsening heart failure due to fluid overload (congestion) are common. Agents that treat congestion without causing electrolyte abnormalities or worsening renal function are needed. Tolvaptan is an oral vasopressin (V2) antagonist that decreases body weight and increases urine volume without inducing renal dysfunction or hypokalemia. The Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial is evaluating mortality, morbidity, and patient-assessed global clinical status in patients treated with tolvaptan compared with standard care. Methods and Results: Patients are eligible for inclusion if they have a reduced left ventricular ejection fraction and are hospitalized for worsening heart failure with evidence of systemic congestion. Patients are randomized 1:1 to tolvaptan 30 mg/day or matching placebo for a minimum of 60 days. Time to all-cause mortality and time to cardiovascular mortality or heart failure hospitalization are the coprimary end points. Patient-assessed global clinical status and quality of life are also evaluated. EVEREST will be continued until 1065 deaths occur. As of April 18, 2005, 2260 patients have been enrolled. Conclusion: Tolvaptan has been shown to reduce body weight in patients with worsening heart failure without inducing renal dysfunction or causing hypokalemia. The results of EVEREST will determine whether these effects translate into improved clinical outcomes.

AB - Background: Hospitalizations for worsening heart failure due to fluid overload (congestion) are common. Agents that treat congestion without causing electrolyte abnormalities or worsening renal function are needed. Tolvaptan is an oral vasopressin (V2) antagonist that decreases body weight and increases urine volume without inducing renal dysfunction or hypokalemia. The Efficacy of Vasopressin antagonism in Heart Failure Outcome Study with Tolvaptan (EVEREST) trial is evaluating mortality, morbidity, and patient-assessed global clinical status in patients treated with tolvaptan compared with standard care. Methods and Results: Patients are eligible for inclusion if they have a reduced left ventricular ejection fraction and are hospitalized for worsening heart failure with evidence of systemic congestion. Patients are randomized 1:1 to tolvaptan 30 mg/day or matching placebo for a minimum of 60 days. Time to all-cause mortality and time to cardiovascular mortality or heart failure hospitalization are the coprimary end points. Patient-assessed global clinical status and quality of life are also evaluated. EVEREST will be continued until 1065 deaths occur. As of April 18, 2005, 2260 patients have been enrolled. Conclusion: Tolvaptan has been shown to reduce body weight in patients with worsening heart failure without inducing renal dysfunction or causing hypokalemia. The results of EVEREST will determine whether these effects translate into improved clinical outcomes.

KW - Clinical trials

KW - Heart failure

KW - Morbidity

KW - Mortality

KW - Vasopressin

UR - http://www.scopus.com/inward/record.url?scp=20944445209&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=20944445209&partnerID=8YFLogxK

U2 - 10.1016/j.cardfail.2005.03.009

DO - 10.1016/j.cardfail.2005.03.009

M3 - Article

C2 - 15880334

AN - SCOPUS:20944445209

VL - 11

SP - 260

EP - 269

JO - Journal of Cardiac Failure

JF - Journal of Cardiac Failure

SN - 1071-9164

IS - 4

ER -