Clinical Trial

Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk

Study acronym: ME-HF
Recruiting
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Summary
This study will evaluate the Heartfelt device, a novel, passive monitoring system that detects early signs of fluid build-up in patients (oedema) with heart failure by measuring changes in foot and lower leg volume through capture of 3D images. The trial will assess whether this device, when added to standard NHS care, improves quality of life and reduces heart failure-related events compared to standard care alone.
Protocol Amendment History 2 changes
notable Primary completion moved earlier: 2027-01-31 -> 2026-12-31 2026-07-29
notable Trial sites expanded: 1 -> 18 locations 2026-05-21
Trial Details
NCT Number NCT07067658
Lead Sponsor Heartfelt Technologies
Collaborators: Manchester University NHS Foundation Trust, University of Glasgow
Conditions Heart Failure
Enrollment 300 participants
Start Date 2025-12-18
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-28