A Multicenter Randomized Controlled Trial of a Digital Health Intervention for Medication Optimization in Heart Failure: The ENGAGE-HF Trial Outcomes

Background: Despite clear evidence that guideline-directed medical therapy (GDMT) significantly reduces mortality and hospitalizations in patients with heart failure (HF) with reduced and mildly reduced ejection fraction, real-world implementation remains suboptimal. Digital health interventions may promote GDMT titration after hospital discharge. Methods: The ENGAGE-HF trial was a multicenter, two-arm, open-label, randomized controlled trial across three academic centers, funded by the AHA Strategically Focused Research Network (SFRN) for Health Technology and Innovation. Patients recently hospitalized with HF, with or without a primary hospital diagnosis of HF, and LVEF <50% receiving suboptimal GDMT were randomized 1:1 to either the ENGAGE-HF app or usual care for 90 days. The ENGAGE-HF intervention consisted of a patient-facing mobile app and a clinician dashboard overseen by study coordinators. The primary outcome was the Medication Optimization Score (MOS, scale 0-100%) at 90 days. Secondary outcomes were individual GDMT therapies and the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score at 90 days. Results: A total of 134 participants were randomized. At 90 days, the adjusted MOS was significantly higher in the ENGAGE-HF group compared to the control group (83.7% vs. 74.0%, p = 0.010). Results remained consistent across multiple sensitivity analyses. Overall prescribing prevalence increased more in the ENGAGE-HF group for MRAs (+15.9 vs. +2.5 percentage points) and SGLT2 inhibitors (+10.9 vs. +2.5 percentage points). Furthermore, the ENGAGE-HF group demonstrated greater increases in achieving target doses for ARNI (+18.8% vs. +6.3%) and beta-blockers (+8.5% vs. +0.6%). KCCQ-23 CSS at 90 days was 75.2 (SE 2.6) in the intervention group versus 72.2 (SE 2.6) in the control group (between-group p = 0.40). Conclusions: ENGAGE-HF, a digital health intervention that integrates remote monitoring, patient engagement, and clinical decision support, significantly improved GDMT optimization at 90 days compared with usual care among patients with HF. Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT06750549