Conduct of Clinical Trials in Acute Heart Failure: Regional Differences in Heart Failure Clinical Trials

被引:7
作者
Fiuzat, Mona [1 ]
Califf, Robert M. [1 ,2 ]
机构
[1] Duke Univ, Med Ctr, Durham, NC 27710 USA
[2] Duke Translat Med Inst, Durham, NC USA
关键词
Heart failure; Regional differences; Clinical trials; BETA-BLOCKER BUCINDOLOL; QUALITY-OF-CARE; BETA(1)-ADRENERGIC RECEPTOR; MYOCARDIAL-INFARCTION; SURVIVAL TRIAL; SURVEY PROGRAM; UNITED-STATES; MERIT-HF; CIBIS-II; POLYMORPHISM;
D O I
10.1016/j.hfc.2011.06.004
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Clinical trials are often conducted globally. Differences in standard of care, patient populations including genetic and phenotypic differences, disease etiologies, rates of comorbidities, ascertainment of endpoints, and differences in concomitant therapies and medical culture may influence subsequent outcomes. There has been little consensus on how clinical trial results should be evaluated. This article reviews the differences in cardiovascular trial results by geographic region, offers potential explanations for these differences, and suggests methods for standardization of trial results.
引用
收藏
页码:539 / +
页数:7
相关论文
共 27 条
[1]   In-hospital mortality in patients with acute decompensated heart failure requiring intravenous vasoactive medications - An analysis from the Acute Decompensated Heart Failure National Registry (ADHERE) [J].
Abraham, WT ;
Adams, KF ;
Fonarow, GC ;
Costanzo, MR ;
Berkowitz, RL ;
LeJemtel, TH ;
Cheng, ML ;
Wynne, J .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2005, 46 (01) :57-64
[2]  
[Anonymous], N ENGL J MED
[3]  
[Anonymous], 1998, N ENGL J MED, V339, P436
[4]   Results of the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) trial by geographical region [J].
Black, HR ;
Elliott, WJ ;
Grandits, G ;
Grambsch, P ;
Lucente, T ;
Neaton, JD ;
Grimm, RH ;
Hansson, L ;
Lacourcière, Y ;
Muller, JE ;
Sleight, P ;
Weber, MA ;
White, WB ;
Williams, GH ;
Witte, J ;
Zanchetti, A ;
Anders, RJ .
JOURNAL OF HYPERTENSION, 2005, 23 (05) :1099-1106
[5]   Continental Differences in Clinical Characteristics, Management, and Outcomes in Patients Hospitalized With Worsening Heart Failure Results From the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) Program [J].
Blair, John E. A. ;
Zannad, Faiez ;
Konstam, Marvin A. ;
Cook, Thomas ;
Traver, Brian ;
Burnett, John C., Jr. ;
Grinfeld, Liliana ;
Krasa, Holly ;
Maggioni, Aldo P. ;
Orlandi, Cesare ;
Swedberg, Karl ;
Udelson, James E. ;
Zimmer, Christopher ;
Gheorghiade, Mihai .
JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 2008, 52 (20) :1640-1648
[6]   An α2C-Adrenergic Receptor Polymorphism Alters the Norepinephrine-Lowering Effects and Therapeutic Response of the β-Blocker Bucindolol in Chronic Heart Failure [J].
Bristow, Michael R. ;
Murphy, Guinevere A. ;
Krause-Steinrauf, Heidi ;
Anderson, Jeffrey L. ;
Carlquist, John F. ;
Thaneemit-Chen, Surai ;
Krishnan, Vaishali ;
Abraham, William T. ;
Lowes, Brian D. ;
Port, J. David ;
Davis, Gordon W. ;
Lazzeroni, Laura C. ;
Robertson, Alastair D. ;
Lavori, Phillip W. ;
Liggett, Stephen B. .
CIRCULATION-HEART FAILURE, 2010, 3 (01) :21-28
[7]   A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: The Flolan International Randomized Survival Trial (FIRST) [J].
Califf, RM ;
Adams, KF ;
McKenna, WJ ;
Gheorghiade, M ;
Uretsky, BF ;
McNulty, SE ;
Darius, H ;
Schulman, K ;
Zannad, F ;
HandbergThurmond, E ;
Harrell, FE ;
Wheeler, W ;
SolerSoler, J ;
Swedberg, K .
AMERICAN HEART JOURNAL, 1997, 134 (01) :44-54
[8]   The EuroHeart Failure survey programme - a survey on the quality of care among patients with heart failure in Europe - Part 1: patient characteristics and diagnosis [J].
Cleland, JGF ;
Swedberg, K ;
Follath, F ;
Komajda, M ;
Cohen-Solal, A ;
Aguilar, JC ;
Dietz, R ;
Gavazzi, A ;
Hobbs, R ;
Korewicki, J ;
Madeira, HC ;
Moiseyev, VS ;
Preda, I ;
van Gilst, WH ;
Widimsky, J ;
Freemantle, N ;
Eastaugh, J ;
Mason, J .
EUROPEAN HEART JOURNAL, 2003, 24 (05) :442-463
[9]   Association between beta-1 and beta-2 adrenergic receptor gene polymorphisms and the response to beta-blockade in patients with stable congestive heart failure [J].
de Groote, P ;
Helbecque, N ;
Lamblin, N ;
Hermant, X ;
Mc Fadden, E ;
Foucher-Hossein, C ;
Amouyel, P ;
Dallongeville, J ;
Bauters, C .
PHARMACOGENETICS AND GENOMICS, 2005, 15 (03) :137-142
[10]   A comparative analysis of the results from 4 trials of β-blocker therapy for heart failure:: BEST, CIBIS-II, MERIT-HF, and COPERNICUS [J].
Domanski, MJ ;
Krause-Steinrauf, H ;
Massie, BM ;
Deedwania, P ;
Follmann, D ;
Kovar, D ;
Murray, D ;
Oren, R ;
Rosenberg, Y ;
Young, J ;
Zile, M ;
Eichhorn, E .
JOURNAL OF CARDIAC FAILURE, 2003, 9 (05) :354-363