American Heart Journal
Volume 146, Issue 2 , Pages 250-257 , August 2003

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

  • Frederick A Masoudi, MD, MSPH

      Affiliations

    • Denver Health Medical Center, Denver, Colo, USA
    • University of Colorado Health Sciences Center, Denver, Colo, USA
    • Colorado Foundation for Medical Care, Aurora, Colo, USA
    • Corresponding Author InformationReprint requests: Frederick A. Masoudi, MD, MSPH, Division of Cardiology, Denver Health Medical Center, 777 Bannock St, MC 0960, Denver, CO 80204, USA.
    • ,
  • Edward P Havranek, MD

      Affiliations

    • Denver Health Medical Center, Denver, Colo, USA
    • University of Colorado Health Sciences Center, Denver, Colo, USA
    • Colorado Foundation for Medical Care, Aurora, Colo, USA
    • ,
  • Pam Wolfe, MA, MS

      Affiliations

    • Colorado Foundation for Medical Care, Aurora, Colo, USA
    • ,
  • Cary P Gross, MD

      Affiliations

    • Yale University School of Medicine, New Haven, Conn, USA
    • ,
  • Saif S Rathore, MPH

      Affiliations

    • Yale University School of Medicine, New Haven, Conn, USA
    • ,
  • John F Steiner, MD, MPH

      Affiliations

    • University of Colorado Health Sciences Center, Denver, Colo, USA
    • ,
  • Diana L Ordin, MD, MPH

      Affiliations

    • Center for Medicare and Medicaid Services, Boston, Mass, USA
    • ,
  • Harlan M Krumholz, MD

      Affiliations

    • Yale University School of Medicine, New Haven, Conn, USA

Received 8 July 2002 ,Accepted 16 October 2002.

References 

  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;316:1429–1435
  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;353:2001–2007
  4. CIBIS Investigators and Committees . A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS). Circulation. 1994;90:1765–1773
  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;341:709–717
  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;33:1948–1955
  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;98:2282–2289
  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;341:2061–2067
  9. Cameron HJ, Williams BO. Clinical trials in the elderly (should we do more?). Drugs Aging. 1996;9:307–310
  10. Gurwitz JH, Col NF, Avorn J. The exclusion of the elderly and women from clinical trials in acute myocardial infarction. JAMA. 1992;268:1417–1422
  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;279:1351–1357
  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;58:1063–1066
  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;343:475–480
  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;159:505–510
  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;285:1441–1446
  21. Goff DC, 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

☆ Dr Masoudi is supported by NIH Research Career Award K08-AG01011. Dr Gross is supported by a Cancer Prevention, Control and Polulation Sciences Career Development Award (1K07CA-90402) and the Claude D. Pepper Older Americans Independence Center at Yale University (P30AG21342).

PII: S0002-8703(03)00189-3

doi: 10.1016/S0002-8703(03)00189-3

American Heart Journal
Volume 146, Issue 2 , Pages 250-257 , August 2003

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