Digital Health Intervention to Optimize Heart Failure Management After Hospital Discharge in Brazil (OPT-HF): A Randomized Clinical Trial.

BACKGROUND: Barriers to optimizing guideline-directed medical therapy (GDMT) for heart failure include infrequent clinical visits, clinician inertia, and poor patient knowledge. Digital health interventions (DHIs) may mitigate these barriers, but evidence from low- and middle-income countries is limited. We evaluated whether a DHI would improve GDMT use and other outcomes in Brazil. METHODS: We enrolled adults admitted for heart failure with ejection fraction <50% and GDMT gaps (≥1 GDMT class not started or ≥2 classes ≤50% target dose) across 5 Brazilian public hospitals from November 2023 to August 2025. Participants were randomized to usual care or the DHI comprising a patient-facing app linked to a provider dashboard, supporting nurse-led remote monitoring, cardiologist teleconsultations, and self-care education. The primary outcome was the between-group difference in mean heart failure GDMT score (0-12) at 90 days. Secondary outcomes included differences in health status, self-care, hospitalization rates, and all-cause mortality. Intention-to-treat analyses used baseline-adjusted linear regression and estimated risk ratios. RESULTS: =0.048), with no statistically significant difference for deaths. CONCLUSIONS: In patients hospitalized for heart failure in Brazil, a context-adapted DHI improved GDMT use, self-care, and reduced hospitalizations. These findings provide early randomized evidence supporting DHI for GDMT optimization in low-resource settings. REGISTRATION: URL: https://ensaiosclinicos.gov.br/rg/RBR-10vpf9bm; Unique identifier: U1111-1295-1864.