REMODEL-HF
REMODEL-HF (Remote Monitoring and Optimization of Heart Failure Therapy)
Clinical validation of a wearable monitoring device, called the Heart Failure Management System (HFMS) to demonstrate improved heart failure management outcomes (hospitalizations, mortality, and biomarker improvement).
Study overview
REMODEL‑HF is a prospective, multi-center, open-label randomized controlled trial evaluating the impact of the Heart Failure Management System (HFMS) on heart failure outcomes. The study compares HFMS-based remote monitoring plus standard of care versus standard of care alone in patients recently hospitalized for acute heart failure.
Objectives
Primary
- To determine whether HFMS-guided management improves a hierarchical composite outcome at 90 days consisting of:
- Cardiovascular death
- Heart failure hospitalization
- Unplanned emergency visits requiring IV diuretics
- Change in NT‑proBNP
Secondary
- Improve GDMT optimization
- Improve quality of life (KCCQ, EQ‑5D)
- Delay time to first HF event (death/hospitalization)
- Assess long-term outcomes at 365 days
Study design
- Prospective, multi-center, open-label randomized controlled trial
- 1:1 randomization:
- Intervention: HFMS + standard of care
- Control: standard of care alone
- Device wear: 90 days
- Follow-up duration: up to 365 days
Participating sites
- Up to ~45 sites across Europe
Consortium partners
Organisations contributing sites, technology, or expertise to this clinical study.