Pharmacist-led intervention for optimal heart failure medications: A pilot randomized controlled trial

Abstract Background: Many patients with heart failure with reduced ejection fraction (HFrEF) do not receive optimal pharmacotherapy. Several health systems have incorporated pharmacist-led medication optimization for HFrEF, but this has not been assessed in a randomized controlled trial (RCT). The aim of this pilot RCT was to determine the feasibility of conducting a larger, definitive RCT of pharmacist-led HFrEF medication optimization on top of usual multidisciplinary care. Methods: This was a single-centre, parallel-group, open-label, pilot RCT conducted within a heart function clinic. Eligible patients with New York Heart Association class I–III HFrEF were randomized to usual care with or without pharmacist-led HFrEF medication optimization. Primary feasibility outcomes were recruitment (proportion of eligible patients at screening and recruitment rate), retention, intervention fidelity, and patient-reported outcome measure (PROM) completion. Results: Between March 2023 and May 2024, we screened 423 patients to randomize 42 participants. Recruitment stopped before reaching the target sample size of 60 participants due to slow enrollment (2.2 versus ≥8 monthly anticipated), mainly due to low eligibility. Participants’ mean age was 64.7 years, 24% were female, and baseline use of angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor neprilysin inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter 2 inhibitors was each ≥90%. One of 11 feasibility outcomes (12-month follow-up ≥80%) met the pre-specified feasibility criteria, indicating a need to modify eligibility criteria, the recruitment strategy and setting, and the processes for collecting PROMs. Interpretation and conclusion: This pilot RCT identified several design modifications needed in terms of eligibility, recruitment, and PROM collection to ensure the feasibility of a future definitive trial of pharmacist-led heart failure medication optimization.