Key result
Digital titration platform nearly quadruples HF optimal therapy score improvement at 90 days vs usual care.
Why the study?
Does a digital remote monitoring and titration platform improve the optimization of guideline-directed medical therapy in patients with HFrEF?
RCT (n=122)
open-label
1:1
Yes
Does a digital remote monitoring and titration platform improve the optimization of guideline-directed medical therapy in patients with HFrEF?
Absolute Event Rate: 1.72% vs 0.44%
p-value: p=<0.001
A digital remote monitoring platform providing biweekly titration recommendations significantly improved the optimization of guideline-directed medical therapy in HFrEF patients over 90 days.
BACKGROUND: Less 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. METHODS: AIM-POWER 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. RESULTS: We 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; P <0.001). CONCLUSIONS: In 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.
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DeVore et al. (2025) conducted an RCT in Heart failure with reduced ejection fraction (n=122). BiovitalsHF digital intervention vs. Usual care was evaluated on Between-group difference in the change in an HF optimal therapy score (p=<0.001). A digital intervention to guide pharmacological therapy optimization significantly increased the heart failure optimal therapy score at 90 days compared to usual care (change of 1.72 vs 0.44; P<0.001).
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