Rationale and Design of the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure

Background Despite overwhelming evidence of clinical benefit for patients with heart failure (HF), the uptake of guideline‐directed medical therapies (GDMT) has been slow. Collaborative approaches are critically needed to improve alignment between evidence and clinical practice. Many strategies proposed to improve GDMT implementation have been either ineffective or too resource‐intensive to implement at scale across different practice contexts. Furthermore, most existing approaches focus primarily on patients with HF and reduced EF, despite growing evidence for effective pharmacologic therapy in those with HF and mildly reduced or preserved ejection fraction (HFpEF). Hypothesis Based on this experience, we designed the Cooperative Program for ImpLementation of Optimal Therapy in Heart Failure (COPILOT‐HF) study (NCT05734690). Methods This is a pragmatic, randomized, open‐label intervention trial to compare a comprehensive, remote, navigator‐led, algorithm‐driven strategy for optimization of GDMT prescribing in patients with HF across the full spectrum of ejection fraction with a control intervention focused on patient and provider education regarding the importance of GDMT optimization. Results The primary efficacy endpoint of the study is the proportion of patients receiving optimal HF treatment at 3 months. Additional outcomes of interest include the proportion of patients with optimal HF therapy at 6 months and 12 months as well as health resource utilization, including hospitalizations and deaths. Conclusions COPILOT‐HF will evaluate the effectiveness of an early implementation of a remote pharmacist‐led medication titration strategy across the HF spectrum.