Rationale, design, and baseline characteristics of the virtual care to improve heart failure outcomes (VITAL-HF) trial.

Background: Among patients with heart failure (HF), guideline-directed medical therapy (GDMT) remains underutilized. Remote digital interventions may facilitate rapid initiation and uptitration of GDMT; however, potential benefits have not been evaluated in well-powered trials. The VITAL-HF (Virtual Care to Improve Heart Failure Outcomes) trial assessed the safety and efficacy of a remote, digital intervention targeting GDMT optimization versus usual care in participants with HF with reduced ejection fraction (HFrEF).

Methods: VITAL-HF was a multicenter, randomized-controlled trial of 178 participants with HFrEF. Eligibility included smartphone access, English proficiency, and left ventricular ejection fraction ≤40%. Participants were randomized to receive either the remote, digital intervention (Story Health HF GDMT Titration Program) or usual care for 6 months. The primary outcome was change from baseline in GDMT using the HF Collaboratory Score (HFC), an expert-defined score integrating use and dose of prescribed GDMT. Secondary outcomes included healthcare visits related to symptomatic hypotension, hyperkalemia, and angioedema.

Results: The median age was 66.4 (Q1-Q3: 56.1-73.1) years and 38.8% were female. Major comorbidities included hypertension (71.3%), coronary artery disease (45.5%), atrial fibrillation/flutter (31.5%), and type 2 diabetes (28.1%). At enrollment, the median HFC score was 5 (Q1-Q3: 4-6) with 84.8% on an evidence-based beta blocker, 48.9% on an angiotensin receptor neprilysin inhibitor, 48.9% on a mineralocorticoid receptor antagonist, and 47.2% on a sodium-glucose cotransporter-2 inhibitor.

Conclusions: The VITAL-HF trial results will provide valuable insights into the safety and efficacy of a remote, digital intervention to improve the use and intensification of GDMT for patients with HFrEF.

Trial Registration: ClinicalTrials.gov Identifier: NCT05602454; ClinicalTrials.gov URL: https://clinicaltrials.gov/study/NCT05602454.