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

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 enro...

Full description

Saved in:
Bibliographic Details
Published in:The American heart journal 2003-08, Vol.146 (2), p.250-257
Main Authors: Masoudi, Frederick A, Havranek, Edward P, Wolfe, Pam, Gross, Cary P, Rathore, Saif S, Steiner, John F, Ordin, Diana L, Krumholz, Harlan M
Format: Article
Language:English
Subjects:
Acute coronary syndromes
Adrenergic beta-Antagonists - therapeutic use
Age
Age Factors
Aged
Aged, 80 and over
Angiotensin-Converting Enzyme Inhibitors - therapeutic use
Biological and medical sciences
Cardiology
Cardiology. Vascular system
Clinical trials
Cross-Sectional Studies
Family medical history
Female
Heart
Heart attacks
Heart failure
Heart Failure - complications
Heart Failure - drug therapy
Heart failure, cardiogenic pulmonary edema, cardiac enlargement
Hospitalization
Humans
Male
Medical records
Medical sciences
Medicare
Meetings
Mineralocorticoid Receptor Antagonists - therapeutic use
Older people
Patient Selection
Patients
Population
Randomized Controlled Trials as Topic - standards
Spironolactone - therapeutic use
Studies
United States
Ventricular Dysfunction, Left - complications
Womens health
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. 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. 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
ISSN:0002-8703
1097-6744
DOI:10.1016/S0002-8703(03)00189-3