RecruitingNot ApplicableNCT07067658

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

Sponsor

Heartfelt Technologies

Enrollment

300 participants

Start Date

Dec 18, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether using a special foot-scanning device at home (called Heartfelt) to monitor leg swelling can help people with heart failure avoid hospital admissions by detecting fluid buildup early, before it becomes a crisis. **You may be eligible if...** - You are over 18 with a diagnosis of heart failure (any type) - You are currently taking at least 40 mg per day of furosemide (a water pill) for at least one month - You have been hospitalized for heart failure and have moderate or severe leg swelling in the past year - You live in the UK in a home where the device can be installed **You may NOT be eligible if...** - Both your feet have been amputated - You are mostly bedridden (more than 20 hours per day) - You use a wheelchair indoors regularly or have daily leg bandages - You have end-stage kidney disease (eGFR below 20) - You have severe aortic stenosis or are awaiting a heart procedure - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInstallation of Heartfelt Device

Device installed in the patient's home and capturing foot volume data which are processed in the cloud.

OTHEREnhanced Standard care

Patients with heart failure are advised to weigh daily and to report weight increase to their clinician. They should also report changes in breathlessness, tiredness and other symptoms associated with heart failure decompensation. At the start of the study, they will be reminded (or told) about the importance of self-checks and will be handed a patient booklet (from the British Heart Foundation) to standardise patients' knowledge.

OTHERQuestionnaires

Patients are presented with one or more optional questionnaires (some validated, some bespoke)

DEVICEHeartfelt device alerting system

The Heartfelt device sends alerts on the active comparator arm to the patients directly (audio-visual alert on the device, and app alerts), carers and/or medical professionals.