Diagnostic heterogeneity in clinical trials for congestive heart failure

Paul R. Marantz, M. H. Alderman, J. N. Tobin

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

There are no uniform diagnostic criteria for congestive heart failure. To determine the pattern of diagnostic criteria used, reports of 51 randomized, double-blind, placebo-controlled, clinical drug trials publihed between 1977 and 1985 were reviewed. Only 23 (45%) of the trials specified objective diagnostic criteria beyond treatment history, clinical diagnosis, or functional class. Of these, there were two trials each for digoxin, hydralazine, amrinone, and metoprolol; for each pair, only one study showed therapy beneficial. Of the amrinone pair, the positive study required a lower ejection fraction (< 30% compared with < 45%) and selected patients with more clinical severity. Conversely, for metoprolol, the positive study specified a higher ejection fraction (< 49% compared with < 35%) and selected patients with clinically milder disease, suggesting that conflicting results may relate to differences in study population. Many studies of congestive heart failure are done without explicit diagnostic criteria. Criteria lack uniformity, and such discrepancies may explain conflicting results.

Original languageEnglish (US)
Pages (from-to)55-61
Number of pages7
JournalAnnals of Internal Medicine
Volume109
Issue number1
StatePublished - 1988

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Amrinone
Metoprolol
Heart Failure
Clinical Trials
Hydralazine
Digoxin
Controlled Clinical Trials
History
Placebos
Therapeutics
Pharmaceutical Preparations
Population

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Diagnostic heterogeneity in clinical trials for congestive heart failure. / Marantz, Paul R.; Alderman, M. H.; Tobin, J. N.

In: Annals of Internal Medicine, Vol. 109, No. 1, 1988, p. 55-61.

Research output: Contribution to journalArticle

Marantz, Paul R. ; Alderman, M. H. ; Tobin, J. N. / Diagnostic heterogeneity in clinical trials for congestive heart failure. In: Annals of Internal Medicine. 1988 ; Vol. 109, No. 1. pp. 55-61.
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