CompletedNot Applicable

Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure

United Kingdom70 participantsStarted 2017-01-15

Plain-language summary

The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering from heart failure, who have peripheral oedema. The device is non-contact and does not requires patient compliance to work. It gives an output reading of the patient's lower leg volume. During the study, this measurement will be compared to clinical standard and gold standard measurements as well as clinical grading of peripheral oedema.

Who can participate

Age range

18 Years – 99 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: * Inpatients with admission for de-compensated heart failure requiring increase or initiation of diuretic therapy for fluid congestion. * Patients attending cardiology outpatients at the Royal Brompton hospital with a diagnosis of heart failure and fluid retention. * Cardiology patient without fluid retention (cardiology controls) Non-Cardiology patient without fluid retention (controls) Exclusion Criteria: * Patients unable to provide informed consent. * Unstable arrhythmias in previous 48 hours * Systolic BP\<90mmHg or need for inotropic support * Ulceration on lower limbs (below shin) - excluded from water displacement but could have image recording and calipers * Inability to transfer from bed to chair * Patients with broken skin or cellulitis will not have their foot volume measured using the water displacement equipment to reduce the risk of infection for the patient and other participants.

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

Volume as measured by the Heartfelt-1 device

Timeframe: Within 3 months after patient recruitment or before the end of the study (whichever is soonest).

Trial details

NCT IDNCT02993601

SponsorHeartfelt Technologies

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2017-06-13

View on ClinicalTrials.gov More Heart Failure, Diastolic trials