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

Heart Failure Clinics

Volumn 7, Issue 4, 2011, Pages 539-544

  Fiuzat, Mona ^a   Califf, Robert M ^a,b  

^a DUKE UNIVERSITY MEDICAL CENTER   (United States)

^b DUKE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Clinical trials; Heart failure; Regional differences

Indexed keywords

AMINO TERMINAL PRO BRAIN NATRIURETIC PEPTIDE; BETA ADRENERGIC RECEPTOR BLOCKING AGENT; BISPROLOL; BRAIN NATRIURETIC PEPTIDE; BUCINDOLOL; CARVEDILOL; METOPROLOL; PROSTACYCLIN; TOLVAPTAN; UNCLASSIFIED DRUG;

ACUTE HEART FAILURE; AGE; ALTERNATIVE MEDICINE; BODY WEIGHT; CANADA; CLINICAL TRIAL (TOPIC); COMPARATIVE STUDY; CULTURAL ANTHROPOLOGY; DEFIBRILLATOR; DISEASE SEVERITY; EASTERN EUROPE; EUROPE; GENDER; GENE FREQUENCY; GENETIC POLYMORPHISM; GEOGRAPHY; HEART FAILURE; HEART LEFT VENTRICLE EJECTION FRACTION; HEART MUSCLE REVASCULARIZATION; HEART RATE; HOSPITAL READMISSION; HOSPITALIZATION; HUMAN; LENGTH OF STAY; MORTALITY; NORTH AMERICA; PACEMAKER; PATIENT COMPLIANCE; RACE; REVIEW; RISK FACTOR; RISK REDUCTION; SAMPLE SIZE; SOUTH AMERICA; STANDARDIZATION; SURVIVAL; SYSTOLIC BLOOD PRESSURE; TREATMENT OUTCOME; TREATMENT RESPONSE; UNITED STATES; WESTERN EUROPE;

ACUTE DISEASE; CLINICAL TRIALS AS TOPIC; HEART FAILURE; HUMANS; PATIENT SELECTION; UNITED STATES;

EID: 80052922089     PISSN: 15517136     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.hfc.2011.06.004     Document Type: Review

References (27)

1. Glickman S.W., McHutchison J.G., Peterson E.D., et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med 2009, 360:816-823.
2. Orlandini A., Diaz R., Wojdyla D., et al. Outcomes of patients in clinical trials with ST-segment elevation myocardial infarction among countries with different gross national incomes. Eur Heart J 2006, 27:527-533.
3. Black H.R., Elliott W.J., Grandits G., et al. Results of the Controlled ONset Verapamil INvestigation of Cardiovascular Endpoints (CONVINCE) trial by geographical region. J Hypertens 2005, 23:1099-1106.
4. The PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. Platelet Glycoprotein IIb/IIIa in Unstable Angina: receptor suppression using integrilin therapy. N Engl J Med 1998, 339:436-443.
5. Yusuf S., Hawken S., Ounpuu S., et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet 2004, 364:937-952.
6. Van de Werf F., Topol E.J., Lee K.L., et al. Variations in patient management and outcomes for acute myocardial infarction in the United States and other countries. Results from the GUSTO trial. Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries. JAMA 1995, 273:1586-1591.
7. Califf R.M., Adams K.F., McKenna W.J., et al. A randomized controlled trial of epoprostenol therapy for severe congestive heart failure: the Flolan International Randomized Survival Trial (FIRST). Am Heart J 1997, 134:44-54.
8. Blair J.E., Zannad F., Konstam M.A., et al. 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 Am Coll Cardiol 2008, 52:1640-1648.
9. O'Connor C., Koch B., Fiuzat M.K., et al. All-cause mortality endpoint comparison in large beta-blocker heart failure trials: United States (US) vs Rest of World (ROW). J Am Coll Cardiol 2009, 53(Suppl):A154. [abstract].
10. The CIBIS-II Investigators. The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomised trial. Lancet 1999, 353:9-13.
11. The MERIT-HF Study Investigators. Effect of metoprolol CR/XL in chronic heart failure: metoprolol CR/XL randomised intervention trial in congestive heart failure (MERIT-HF). Lancet 1999, 353:2001-2007.
12. Packer M., Fowler M.B., Roecker E.B., et al. Effect of carvedilol on the morbidity of patients with severe chronic heart failure: results of the carvedilol prospective randomized cumulative survival (COPERNICUS) study. Circulation 2002, 106:2194-2199.
13. A trial of the beta-blocker bucindolol in patients with advanced chronic heart failure. N Engl J Med 2001, 344:1659-1667. Beta-blocker evaluation of survival trial investigators.
14. Cleland J.G., Swedberg K., Follath F., et al. 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. Eur Heart J 2003, 24:442-463.
15. Komajda M., Follath F., Swedberg K., et al. The EuroHeart Failure Survey programme-a survey on the quality of care among patients with heart failure in Europe. Part 2: treatment. Eur Heart J 2003, 24:464-474.
16. Fonarow G.C., Abraham W.T., Albert N.M., et al. Prospective evaluation of beta-blocker use at the time of hospital discharge as a heart failure performance measure: results from OPTIMIZE-HF. J Card Fail 2007, 13:722-731.
17. Abraham W.T., Adams K.F., Fonarow G.C., et al. 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 Am Coll Cardiol 2005, 46:57-64.
18. Tavazzi L., Maggioni A.P., Lucci D., et al. Nationwide survey on acute heart failure in cardiology ward services in Italy. Eur Heart J 2006, 27:1207-1215.
19. Domanski M.J., Krause-Steinrauf H., Massie B.M., et al. A comparative analysis of the results from 4 trials of beta-blocker therapy for heart failure: BEST, CIBIS-II, MERIT-HF, and COPERNICUS. J Card Fail 2003, 9:354-363.
20. Liggett S.B., Mialet-Perez J., Thaneemit-Chen S., et al. A polymorphism within a conserved beta(1)-adrenergic receptor motif alters cardiac function and beta-blocker response in human heart failure. Proc Natl Acad Sci U S A 2006, 103:11288-11293.
21. Bristow M.R., Murphy G.A., Krause-Steinrauf H., et al. An {alpha}2C-Adrenergic receptor polymorphism alters the norepinephrine lowering effects and therapeutic response of the beta blocker bucindolol in chronic heart failure. Circ Heart Fail 2010, 3(1):21-28.
22. O'Connor C.M., Fiuzat M.C., Anand I., et al. Additive effects of b1389 Arg/Gly and a2c 322-325 Wt/Del Adrenergic Receptor Genotype Combinations on Morbidity and Mortality in the BEST Trial. J Card Fail 2008, 14(Suppl 1):S69. [abstract].
23. de Groote P., Helbecque N., Lamblin N., et al. Association between beta-1 and beta-2 adrenergic receptor gene polymorphisms and the response to beta-blockade in patients with stable congestive heart failure. Pharmacogenet Genomics 2005, 15:137-142.
24. Mialet Perez J., Rathz D.A., Petrashevskaya N.N., et al. Beta 1-adrenergic receptor polymorphisms confer differential function and predisposition to heart failure. Nat Med 2003, 9:1300-1305.
25. Mason D.A., Moore J.D., Green S.A., et al. A gain-of-function polymorphism in a G-protein coupling domain of the human beta1-adrenergic receptor. J Biol Chem 1999, 274:12670-12674.
26. McNamara D.M., Holubkov R., Janosko K., et al. Pharmacogenetic interactions between beta-blocker therapy and the angiotensin-converting enzyme deletion polymorphism in patients with congestive heart failure. Circulation 2001, 103:1644-1648.
27. O'Connor C.M., Starling R.C., Hernandez A.F., et al. Effect of nesiritide in patients with acute decompensated heart failure. N Engl J Med 2011, 365:32-43.