Under-Enrollment of Obese Heart Failure with Preserved Ejection Fraction Patients in Major HFpEF Clinical Trials.

ABSTRACT

BACKGROUND: Therapy for heart failure with preserved ejection fraction (HFpEF) remains an unmet need with lack of a consensus definition of HFpEF for inclusion into clinical trials. We evaluated whether hemodynamically characterized patients from a HFpEF referral center met inclusion criteria for 4 major HFpEF trials. METHODS AND RESULTS: Patients were assessed for theoretical inclusion into 4 major clinical trials (I-PRESERVE, RELAX, TOPCAT, and PARAGON-HF). Clinical, echocardiographic and hemodynamic characteristics and cardiovascular outcomes were compared between patients who met the inclusion criteria vs those who did not for each trial. Of 131 patients with HFpEF, 23% of patients met the enrollment criteria for I-PRESERVE, 38% for RELAX, 18% for TOPCAT, and 13% for PARAGON-HF. The top criteria that excluded patients included low natriuretic peptide level, obesity, uncontrolled hypertension, young age, and low hemoglobin. There was no difference in the probability of HF hospitalization or death in patients included or excluded into each clinical trial. CONCLUSIONS: In a cohort with hemodynamic evidence of HFpEF, a low proportion of patients met inclusion criteria for major HFpEF clinical trials, with no difference in outcomes in patients who did or did not meet inclusion criteria. Given relative the lack of proven therapies in HFpEF, consideration should be given to modifying clinical trial enrollment criteria to better represent contemporary patients with HFpEF in future clinical trials.