Clinical investigations: congestive heart failureMost hospitalized older persons do not meet the enrollment criteria for clinical trials in heart failure☆
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
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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).