Abstract Body (Do not enter title and authors here): Background: Despite strong guideline recommendations, GDMT adoption for heart failure remains low. We proposed that a remote pharmacist-led program using non-licensed navigators could enhance GDMT more effectively than provider notification and education alone.
Methods: The Cooperative Program for Implementation of Optimal Therapy in Heart Failure (COPILOT-HF) (NCT05734690) is a pragmatic, randomized, open-label clinical trial comparing two strategies for remote GDMT optimization across the spectrum of HF, regardless of LVEF. Participants (pts) were randomized 1:1 to either a 3-month education-first strategy followed by medication management or simultaneous initiation of both interventions (Figure). The primary efficacy endpoint is the percentage of pts receiving full guideline-directed HF treatment at 3 months. Safety outcomes include kidney complications, hypotension, hospitalizations, and deaths. A prespecified interim analysis was performed after the first 100 pts completed 4 months in the program.
Results: 503 HF pts were enrolled. Mean age was 72yrs, 53% were male and 89% white. Hypertension (87%), obesity (mean BMI 32 kg/m2) and T2D (32%) were common comorbidities, and 29% were hospitalized for HF within 1 year of enrollment. Mean baseline labs were NTproBNP 1302 pg/ml, potassium 4.3 mEq/L, and eGFR 68.6 mL/min/1.73 m2. A total of 174 pts (35%) had an LVEF <50% (including 16% with EF<40%), 26% had EF 50–59%, and 40% had EF≥60%. Baseline medications were: 89% B-blocker, 33% MRA, 32% SGLT2i, and 30% ARNI for EF<50%, and 77% B-blocker, 18% MRA, 2% SGLT2i, and 4% ARNI for EF>=50%. At the interim analysis, 4 pts (8%) in the Education-first arm achieved the 1° EP compared to 27 (54%) in the simultaneous arm (p<0.001). Based on these results, all subsequent pts were enrolled into a single-arm program of simultaneous medication management and education. The last pts was enrolled in February 2025. Navigators completed 16,536 tasks (mean 33.1 per pts ) facilitating patient progress through the program with 1,966 medications (mean 3.9 per pts ) initiated, and 2,967 labs (mean 5.9 per pts ) reviewed. While enrolled, 70 pts were hospitalized, including 10 hospitalized for heart failure.
Conclusions: A strategy of remote medication implementation combined with education appeared to result in a higher proportion of pts with HF receiving optimal medical therapy compared with education first. Final data will be available for presentation at AHA 2025.