A Digital Platform to Optimize Guideline-Directed Heart Failure Therapy: Rationale and Design of the AIM-POWER Trial.

Background: Patients with heart failure (HF) remain at high risk for hospitalization and death, in part, due to underuse of available HF pharmacological therapy. Digital interventions may facilitate rapid initiation and titration of HF pharmacological therapy, but they have not been systematically evaluated in adequately powered, randomized, control trials. In the AIM-POWER study, we evaluated the safety and efficacy of the BiovitalsHF DTx decision-support platform as a strategy to guide optimal initiation and titration of pharmacological therapy in patients with HF with reduced ejection fraction (HFrEF).

Methods and results: We enrolled 122 participants with symptomatic HFrEF (left ventricular ejection fraction ≤ 40%) who had not yet been optimized on HF pharmacological therapy. Participants were randomized 1:1 in an open-label fashion to management; they were supported by BiovitalsHF or usual care. Using wearable home-based monitors and digital scales, the BiovitalsHF platform assembled data regarding patients' status and formulated suggestions regarding initiation and titration of HF pharmacological therapy per published guidelines. These recommendations were provided to site clinicians, but final decisions about prescribing and titration were left to the sites. The primary outcome was the between-group difference in the change in an HF optimal medical therapy score from baseline-90 days.

Conclusion: The results of the AIM-POWER study will provide important insights into digital interventions for HF management and will evaluate the effectiveness of BiovitalsHF in improving the use and dosing of pharmacological therapy for participants with HFrEF.