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The persistent exclusion of older patients from ongoing clinical trials regarding heart failure

Antonio Cherubini1, Joaquim Oristrell, Xavier Pla

  • 1Institute of Gerontology and Geriatrics, Department of Clinical and Experimental Medicine, Policlinico Santa Maria della Misericordia, University of Perugia Medical School, Piazzale Menghini 1, 06156 Perugia PG, Italy. acherub@unipg.it

Archives of Internal Medicine
|March 30, 2011
PubMed

Insights

Older adults are frequently excluded from heart failure clinical trials due to arbitrary age limits or poorly justified criteria. This widespread exclusion limits the generalizability of research findings for this demographic.

Area of Science:

  • Cardiology
  • Clinical Trials
  • Geriatrics

Background:

  • Clinical research often underrepresents elderly patients, particularly in studies for conditions prevalent in older populations like heart failure.
  • This study addresses the gap in understanding the exclusion of older individuals in ongoing heart failure clinical trials.

Purpose of the Study:

  • To investigate the extent of exclusion of older individuals in ongoing heart failure clinical trials.
  • To identify specific exclusion criteria contributing to limited recruitment of elderly patients.

Main Methods:

  • Data from ongoing heart failure clinical trials were extracted from the World Health Organization Clinical Trials Registry Platform.
  • Exclusion criteria were analyzed, categorizing them as arbitrary upper age limits or other potentially limiting factors, and further classified as justified or poorly justified.

Main Results:

  • Over a quarter of heart failure trials (25.5%) imposed arbitrary age limits.
  • Poorly justified exclusion criteria were present in 43.4% of trials, potentially limiting older adult inclusion.
  • Exclusionary practices were more prevalent in trials within the European Union and those sponsored by public institutions.

Conclusions:

  • Despite regulatory recommendations, older individuals remain widely excluded from heart failure clinical trials.
  • The findings highlight a persistent issue in clinical trial design that needs to be addressed to improve representation of the elderly.
Abstract

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