Elderly Patients Continue to Be Excluded from Heart Failure Trials

Although HF is principally a disease of advancing age, the results of many clinical trials may not be generalizable to most elderly patients.

Despite the fact that heart failure (HF) predominantly affects individuals aged ≥65, past clinical trials have often excluded elderly patients, whether explicitly (i.e., upper age exclusions) or implicitly (e.g., exclusions for coexisting conditions common in older persons). Whether previous reports of this disparity have affected the design of more-recent trials is unknown. To find out, investigators identified HF trials registered with the World Health Organization Clinical Trials Registry Platform (which includes the U.S. FDA registry) that were reportedly recruiting patients on December 1, 2008.

Of 251 trials analyzed, more than one quarter (25.5%) had an upper age limit for enrollment; most (80.1%) excluded patients because of coexistin…

Reviewing Author

Frederick A. Masoudi, MD, MSPH, FACC, FAHA

Disclosures

Consultant/Advisory BoardBristol Myers Squibb; CPC Clinical Research

Grant/Research SupportNational Heart, Lung, and Blood Institute

Editorial BoardsUpToDate; American College of Cardiology Self-Assessment Program (SAP)

Leadership Positions in Professional SocietiesAmerican College of Cardiology (Chair, Innovations Committee)