Lessons Learned from Clinical Trials in Acute Heart Failure: Phase 3 Drug Trials

被引:3
|
作者
O'Connor, Christopher M. [1 ]
Fiuzat, Mona [1 ]
机构
[1] Duke Univ, Med Ctr, Div Cardiol, Durham, NC 27710 USA
关键词
Acute heart failure; Phase 3 clinical trials; Endpoints; Efficacy; Safety; RANDOMIZED CONTROLLED-TRIAL; ANTAGONIST; ROLOFYLLINE; NESIRITIDE;
D O I
10.1016/j.hfc.2011.06.013
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Phase 3 clinical trials in acute heart failure are conducted to allow safety and efficacy data to be collected for the evaluation of treatment strategies, including drugs, devices, diagnostics, or nonpharmacological interventions. There are several important features regarding the conduct of phase 3 clinical trials in acute heart failure. This article describes in detail these important aspects of conducting phase 3 clinical trials in an acute heart failure population.
引用
收藏
页码:451 / +
页数:7
相关论文
共 50 条
  • [1] Designing phase 3 sepsis trials: Application of learned experiences from critical care trials in acute heart failure
    Mebazaa A.
    Laterre P.F.
    Russell J.A.
    Bergmann A.
    Gattinoni L.
    Gayat E.
    Harhay M.O.
    Hartmann O.
    Hein F.
    Kjolbye A.L.
    Legrand M.
    Lewis R.J.
    Marshall J.C.
    Marx G.
    Radermacher P.
    Schroedter M.
    Scigalla P.
    Stough W.G.
    Struck J.
    Van den Berghe G.
    Yilmaz M.B.
    Angus D.C.
    [J]. Journal of Intensive Care, 4 (1)
  • [2] Clinical Trials of Pharmacological Therapies in Acute Heart Failure Syndromes Lessons Learned and Directions Forward
    Felker, G. Michael
    Pang, Peter S.
    Adams, Kirkwood F.
    Cleland, John G. F.
    Cotter, Gad
    Dickstein, Kenneth
    Filippatos, Gerasimos S.
    Fonarow, Gregg C.
    Greenberg, Barry H.
    Hernandez, Adrian F.
    Khan, Sadiya
    Komajda, Michel
    Konstam, Marvin A.
    Liu, Peter P.
    Maggioni, Aldo P.
    Massie, Barry M.
    McMurray, John J.
    Mehra, Mandeep
    Metra, Marco
    O'Connell, John
    O'Connor, Christopher M.
    Pina, Ileana L.
    Ponikowski, Piotr
    Sabbah, Hani N.
    Teerlink, John R.
    Udelson, James E.
    Yancy, Clyde W.
    Zannad, Faiez
    Gheorghiade, Mihai
    [J]. CIRCULATION-HEART FAILURE, 2010, 3 (02) : 314 - 325
  • [3] Ultrafiltration therapy for acute decompensated heart failure: Lessons learned from 2 major trials
    Kazory, Amir
    Ronco, Claudio
    [J]. AMERICAN HEART JOURNAL, 2013, 166 (05) : 799 - 803
  • [4] Lessons to be learned from multicentre clinical trials
    Fairclough, DL
    Cella, D
    [J]. QUALITY OF LIFE RESEARCH, 1997, 6 (7-8) : 101 - 101
  • [5] Arteriogenesis: Lessons learned from clinical trials
    Baklanov, D
    Simons, M
    [J]. ENDOTHELIUM-JOURNAL OF ENDOTHELIAL CELL RESEARCH, 2003, 10 (4-5): : 217 - 223
  • [6] Lessons learned from clinical trials of asthma
    Greenberger, Paul A.
    [J]. ALLERGY AND ASTHMA PROCEEDINGS, 2019, 40 (06) : 410 - 413
  • [7] Lessons learned from clinical trials in SLE
    Strand, Vibeke
    [J]. AUTOIMMUNITY REVIEWS, 2007, 6 (04) : 209 - 214
  • [8] Conduct of Clinical Trials in Acute Heart Failure: Regional Differences in Heart Failure Clinical Trials
    Fiuzat, Mona
    Califf, Robert M.
    [J]. HEART FAILURE CLINICS, 2011, 7 (04) : 539 - +
  • [9] Lessons learned during an echo certification process in heart failure trials
    Krishnan, A. K. Radha
    Morris, D. A.
    Belyavskiy, E.
    Frydas, A.
    Huang, F.
    Kropf, M.
    Marandi, S.
    Pieske, B.
    Pieske-Kraigher, E.
    [J]. EUROPEAN JOURNAL OF HEART FAILURE, 2018, 20 : 249 - 249
  • [10] A Review of Phase II Acute Heart Failure Syndromes Clinical Trials
    Pang, Peter S.
    Gheorghiade, Mihai
    [J]. HEART FAILURE CLINICS, 2011, 7 (04) : 441 - +