Digital Platform to Optimize Guideline-Directed Heart Failure Therapy: Results of the AIM-POWER Trial.

backgroundLess than 1 in 3 patients in the United States with heart failure (HF) with reduced ejection fraction are receiving guideline-recommended medical therapy. Remote titration programs outside of structured episodes of care may address this issue and improve the implementation of guideline-recommended care.

methodsAIM-POWER (Artificial Intelligence Mobile Health Trial of a Digital Platform to Optimize Guideline-Directed Heart Failure Therapy Using Wearable Sensors) was a multicenter, open-label, clinical trial of participants with HF with reduced ejection fraction who were not optimized on medical therapy designed to evaluate the safety and efficacy of a digital intervention to guide optimal initiation and titration of pharmacological therapy. Participants were randomized 1:1 to a BiovitalsHF intervention or usual care and followed for 90 days. Participants receiving the intervention assessed their weight daily, and blood pressure and heart rate twice daily. These data were collected remotely and used to create outpatient medication titration recommendations from the BiovitalsHF platform to site clinicians every 2 weeks. The primary outcome was the between-group difference in the change in an HF optimal therapy score.

resultsWe randomized 122 participants at 21 sites in the United States. The mean (±SD) age of the participants was 61.6±12.4 years, and 69% were male. The mean left ventricular ejection fraction was 29±6.7%, and the mean baseline HF optimal therapy score was 3.8±1.8 (range, 0-8). At 90 days after randomization, the change in the score was significantly greater in the intervention group than usual care group (1.72 ±1.75 intervention versus 0.44 ±1.18 usual care;

conclusionsIn participants with HF with reduced ejection fraction who were not yet optimized on medical therapy, a digital intervention that focused on the optimization of HF pharmacological therapy resulted in a significantly greater change in an HF optimal therapy score at 90 days than usual care. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04191330.