ClinicaliQ Trial Snapshot
- Monitoring Oedema in Heart Failure to Improve Function and Reduce Hospitalisation Risk — Recruiting • Non-phase study • Cardiology / Cardiovascular • NCT07067658.
- What is being tested: The Heartfelt device, a non-invasive 3D imaging system that passively monitors foot and lower leg volume to detect early fluid accumulation (oedema) in heart failure patients, enabling earlier clinical intervention before symptom progression.
- Patient eligibility: The trial includes patients with diagnosed heart failure (likely across ejection fraction categories) who require regular monitoring; specific age, functional status, and disease severity criteria would determine final recruitment parameters.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : Participants are eligible if they meet all General Criteria and at least one of Pathways A, B, or C. 1. General Criteria (all participants must meet) * Aged ≥18 years, AND * Diagnosis of heart failure (any aetiology or LVEF classification), AND * Documented or patient-reported moderate to severe leg oedema, AND * Lives in the UK with a home environment suitable for installation of the Heartfelt device Pathway A: High risk patient with daily diuretics * Currently prescribed ≥40 mg/day of furosemide (or equivalent loop diuretic, eg. bumetanide or torsemide) for at least one month, AND * Any cardiorespiratory admission** in the last 12 months (Includes outpatient IV diuretics, subcutaneous loop diuretics, or escalation to combination therapy with a loop diuretic and a thiazide or thiazide-like diuretic (eg: metolazone, bendroflumethiazide, indapamide etc). Pathway B: High risk patient without daily diuretics * Patients prescribed SGLT2 inhibitor (eg; dapagliflozin or empagliflozin) , AND * Patients prescribed oral furosemide ≥40mg/day but advised to take it only as needed AND either: a) at least two admissions* caused or complicated by worsening heart failure in the previous 12 months, OR b) a measurement of plasma NT-proBNP exceeding 1,000 ng/L (pg/mL) in the…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.