Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk (NCT07067658) | Clinical Trial Compass
RecruitingNot Applicable
Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk
United Kingdom300 participantsStarted 2025-12-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. NYHA class III and IV (score: 2)
. ≥80 mg/day Furosemide or equivalent loop diuretic (score: 2)
. \<3 Number of times the patient has weighed themselves in the last 2 weeks (score: 2)
. Help for essential daily activities required (score: 2)
. GRMT score \<5 (score: 2)
. Use of a walking stick, walker or mobility scooter (score: 2)
. \>2 Number of HF events in last 12 months (score: 2)
. Aged over 75 (score: 1)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite Clinical Events
Timeframe: Over 12-months period.
2
Health-Related Quality of Life (EQ-5D-5L)
Timeframe: Collected at baseline, 3, 6, 9, and 12 months