Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials

Abstract

Background Despite the importance of age, sex, and race/ethnicity representativeness in clinical trials, limited data exist regarding the enrollment trends of these groups in contemporary heart failure (HF) trials. Objective We aimed to characterize the representation of older patients, women, and racial and ethnic minorities in HF trials. Methods We performed a systematic search of HF trials published between January 2001 and December 2016 that enrolled over 400 participants using PubMed/MEDLINE and ClinicalTrials.gov. A total of 118 trials that cumulatively enrolled 215,508 subjects were included. Trial findings were compared with large epidemiological studies indexed to hospitalization status and ejection fraction. Results Median number of participants per trial was 994 (IQR 543-1899) enrolled from a median of 82 (IQR 28-171) sites. Overall, 94 (80%) of trials enrolled patients with HF with reduced ejection fraction (HFrEF) exclusively. Mean age of trial participants was 65±11 years and 27% were women; no significant temporal trends were observed (P≥0.60 for both, Figure). Chronic HF with preserved ejection fraction (HFpEF) trials enrolled older participants (mean age of 71±7 years compared to 65±11 year for HFrEF and 66±12 years for acute HF (AHF) trials (P=0.01). Corresponding average ages in US epidemiological studies were 69 years for HFrEF, and 73 year for both HFpEF and AHF patients. HFpEF trials had a higher proportion of women (56%) compared with HFrEF (24%), or AHF (32%), P Conclusion In contemporary HF trials, older patients and women are consistently underrepresented. Race/ethnicity data are reported in less than half of the trials; when reported, such data show that enrollment of non-White patients increased over time