Most hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure

American Heart Journal

Volumn 146, Issue 2, 2003, Pages 250-257

  Masoudi, Frederick A ^a,b,c   Havranek, Edward P ^a,b,c   Wolfe, Pam ^c   Gross, Cary P ^d   Rathore, Saif S ^d   Steiner, John F ^b   Ordin, Diana L ^e   Krumholz, Harlan M ^d  

^a DENVER HEALTH MEDICAL CENTER   (United States)

^b UNIVERSITY OF COLORADO   (United States)

^c Colorado Foundation for Medical Care ^*  (United States)

^d YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^e Centers for Medicare and Medicaid Services   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA ADRENERGIC RECEPTOR BLOCKING AGENT; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; SPIRONOLACTONE;

AGED; ARTICLE; CLINICAL RESEARCH; HEART FAILURE; HEART LEFT VENTRICLE CONTRACTION; HEART LEFT VENTRICLE EJECTION FRACTION; HOSPITAL PATIENT; HUMAN; MAJOR CLINICAL STUDY; PATIENT SELECTION; PRIORITY JOURNAL;

EID: 0042991391     PISSN: 00028703     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0002-8703(03)00189-3     Document Type: Article

References (21)

1. CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure: results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987;316:1429-35.
2. SOLVD Investigators. Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure. N Engl J Med 1991;325:293-302.
3. MERIT-HF Investigators. Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Lancet 1999;353:2001-7.
4. CIBIS Investigators and Committees. A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS). Circulation 1994;90:1765-73.
5. Pitt B, Zannad F, Remme WJ, et al. The effect of spironolactone on morbidity and mortality in patients with severe heart failure. Randomized Aldactone Evaluation Study Investigators. N Engl J Med 1999;341:709-17.
6. Vasan RS, Larson MG, Benjamin EJ, et al. Congestive heart failure in subjects with normal versus reduced left ventricular ejection fraction: prevalence and mortality in a population-based cohort. J Am Coll Cardiol 1999;33:1948-55.
7. Senni M, Tribouilloy CM, Rodeheffer RJ, et al. Congestive heart failure in the community: a study of all incident cases in Olmsted County, Minnesota, in 1991. Circulation 1998;98:2282-9.
8. Hutchins LF, Unger JM, Crowley JJ, et al. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 1999;341:2061-7.
9. Cameron HJ, Williams BO. Clinical trials in the elderly: should we do more? Drugs Aging 1996;9:307-10.
10. Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA 1992;268:1417-22.
11. Lee PY, Alexander KP, Hammill BG, et al. Representation of elderly persons and women in published randomized trials of acute coronary syndromes. JAMA 2001;286:708-13.
12. Marciniak TA, Ellerbeck EF, Radford MJ, et al. Improving the quality of care for Medicare patients with acute myocardial infarction: results from the Cooperative Cardiovascular Project. JAMA 1998;279:1351-7.
13. Chidsey CA, Sonnenblick EH, Morrow AG, et al. Norepinephrine stores and contractile force of papillary muscle from the failing human heart. Circulation 1966;33:43-51.
14. Braunwald E, Chidsey CA. The adrenergic nervous system in the control of the normal and failing heart. Proc Royal Soc Med 1965;58:1063-6.
15. Harris DJ, Douglas PS. Enrollment of women in cardiovascular clinical trials funded by the National Heart, Lung, and Blood Institute. N Engl J Med 2000;343:475-80.
16. Dicker RC, Han LF, Mancone JJ. Quality of care surveillance using administrative data, 1996. Quality resume, no. 2. 1998. Health Care Financing Administration.
17. Croft JB, Giles WH, Pollard RA, et al. Heart failure survival among older adults in the United States: a poor prognosis for an emerging epidemic in the Medicare population. Arch Intern Med 1999;159:505-10.
18. Krumholz HM, Parent EM, Tu N, et al. Readmission after hospitalization for congestive heart failure among Medicare beneficiaries. Arch Intern Med 1997;157:99-104.
19. Masoudi FA, Havranek EP, Krumholz HM. The burden of chronic congestive heart failure in older persons: magnitude and implications for policy and research. Heart Failure Rev 2002;7:9-16.
20. McKee PA, Castelli WP, McNamara PM, Kannel WB. The natural history of congestive heart failure: the Framingham study. N Engl J Med 1971;285:1441-6.
21. Goff DC Jr, Pandey DK, Chan FA, et al. Congestive heart failure in the United States: is there more than meets the I(CD code)? The Corpus Christi Heart Project. Arch Intern Med 2000;160:197-202.