Elsevier

American Heart Journal

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

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

https://doi.org/10.1016/S0002-8703(03)00189-3Get rights and content

Abstract

Background

Although it is widely accepted that clinical trials in heart failure may not apply to older populations, the magnitude of the discrepancy between trial populations and patients seen in community-based practice are not known. Our objective was to determine the proportion of older persons meeting enrollment criteria of randomized controlled trials of agents that prolong life in heart failure.

Methods

We conducted a cross-sectional study of Medicare beneficiaries >64 years old with the principal diagnosis of heart failure who were discharged from acute care hospitals in the United States between April 1998 and March 1999. Enrollment criteria of the Studies of Left Ventricular Dysfunction (SOLVD), Metroprolol CR/LX Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF), and Randomized Aldactone Evaluation Study (RALES) trials were applied to the population, and the proportions meeting the criteria were determined by subgroups of age and sex.

Results

Of the 20,388 patients studied, 18%, 13%, and 25% met the enrollment criteria of the SOLVD, MERIT-HF, and RALES trials, respectively. Although trial eligibility was less than a third for any sex or age group, significantly fewer women than men met trial criteria (13% vs 23% for SOLVD, 11% vs 17% for MERIT-HF, and 21% vs 32% for RALES, P <.0001 for all). The oldest patients were also less likely to fulfill enrollment criteria. The proportion of all patients not included because of preserved left ventricular systolic function was twice as large as the proportion meeting the inclusion criteria for any trial.

Conclusions

A minority of hospitalized older persons with heart failure fit the profile of populations of clinical trials. There is an urgent need for research in heart failure for typical heart failure patients, including the very old, women, and patients with preserved left ventricular systolic function.

Section snippets

Study sample

We used data from the National Heart Failure Project (NHF), a quality improvement initiative sponsored by the Centers for Medicare and Medicaid Services (CMS, the former Health Care Financing Administration). Detailed clinical information was abstracted from the medical records of 37,500 fee-for-service Medicare beneficiaries who were hospitalized with a principal discharge diagnosis of heart failure (International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM]

Patient population

A total of 37,500 hospital discharges met the criteria for chart review for the NHF sample. Of these hospitalizations, 32,716 (87%) were for patients who were at least 65 years old and discharged alive. Of these older survivors, 20,388 (62%) had an assessment of left ventricular systolic function recorded in the hospital chart, constituting the primary sample for this study.

The 12,328 subjects without documentation of left ventricular systolic function, when compared with the primary study

Discussion

In this national cohort of older persons surviving hospitalization for heart failure, a small proportion met the enrollment criteria of the clinical trials of life-prolonging therapies defining contemporary evidence-based heart failure treatment. Even when restricted to the NHF population with left ventricular systolic dysfunction, no more than half satisfied the trial exclusion criteria for any 1 of the trials. More strikingly, of the entire NHF cohort studied, more than two thirds did not

Acknowledgements

The analyses on which this publication is based were performed under Contract Number 500-99-C001, titled “Utilization and Quality Control Peer Review Organization for the State of Colorado,” sponsored by the Health Care Financing Administration, Department of Health and Human Services. The content of the publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does the mention of trade names, commercial products, or organizations imply

References (21)

  • R.S. Vasan et al.

    Congestive heart failure in subjects with normal versus reduced left ventricular ejection fractionprevalence and mortality in a population-based cohort

    J Am Coll Cardiol

    (1999)
  • Effects of enalapril on mortality in severe congestive heart failureresults of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS)

    N Engl J Med

    (1987)
  • Effect of enalapril on survival in patients with reduced left ventricular ejection fractions and congestive heart failure

    N Engl J Med

    (1991)
  • Effect of metoprolol CR/XL in chronic heart failureMetoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF)

    Lancet

    (1999)
  • A randomized trial of beta-blockade in heart failure. The Cardiac Insufficiency Bisoprolol Study (CIBIS)

    Circulation

    (1994)
  • B. Pitt 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)
  • M. Senni et al.

    Congestive heart failure in the communitya study of all incident cases in Olmsted County, Minnesota, in 1991

    Circulation

    (1998)
  • L.F. Hutchins et al.

    Underrepresentation of patients 65 years of age or older in cancer-treatment trials

    N Engl J Med

    (1999)
  • H.J. Cameron et al.

    Clinical trials in the elderlyshould we do more?

    Drugs Aging

    (1996)
  • J.H. Gurwitz et al.

    The exclusion of the elderly and women from clinical trials in acute myocardial infarction

    JAMA

    (1992)
There are more references available in the full text version of this article.

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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).

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