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New home scanner could keep heart failure patients out of hospital

NCT ID NCT07067658

Disease control Sponsor: Heartfelt Technologies Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study tests a device called Heartfelt that sits in your home and uses 3D images to detect early signs of fluid buildup in the legs and feet, a common problem in heart failure. About 300 people with heart failure and leg swelling will either get the device plus standard care, or standard care alone. The goal is to see if the device helps improve quality of life and reduces hospital visits or deaths over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Heartfelt Device (a passive monitoring system that measures foot and leg volume changes via 3D imaging)
What this could lead to
If successful, this device could help heart failure patients avoid hospital stays by catching fluid buildup early, improving daily life and reducing emergency visits.
What could go wrong
This is a relatively early-stage trial with 300 participants, so results may not apply to all heart failure patients. The device requires a suitable home setup, and its benefit over standard care is not yet proven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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 previous 12 months Pathway C: Implanted Haemodynamic Monitoring Devices (minimum n=10 participants) * Uses an implantable device designed to monitor congestion (e.g. CardioMEMS, HeartLogic, or equivalent) * Enrichment criteria: Patients must also meet a minimum total score of 4 from the characteristics below. 1. NYHA class III and IV (score: 2) 2. ≥80 mg/day Furosemide or equivalent loop diuretic (score: 2) 3. \<3 Number of times the patient has weighed themselves in the last 2 weeks (score: 2) 4. Help for essential daily activities required (score: 2) 5. GRMT score \<5 (score: 2) 6. Use of a walking stick, walker or mobility scooter (score: 2) 7. \>2 Number of HF events in last 12 months (score: 2) 8. Aged over 75 (score: 1) 9. Health issues limiting daily activities (score: 1) 10. Help getting to medical appointment required (score: 1) 11. Problematic / not tolerated uptitration of medications: MRA (score: 1) SGLT2i (score: 1) Other (score: 1) 12. English as a second language (score: 1) 13. eGFR 20-45 (score: 1) 14. Patient unable to regularly attend appointments for any reason (score: 1) 15. \>3 Number of co-morbidities (score: 1) Exclusion Criteria: * Amputation of both feet * Bed-bound for more than 20h per 24h period * Bandages to lower limbs every day * Regular wheelchair user inside their home * No fixed abode * Participation in another interventional trial that may interfere with endpoints * Life expectancy \<6 months, in the opinion of the investigator * Inability to provide informed consent due to cognitive impairment * Language barriers that preclude understanding of trial procedures (unless translation resources are available in relevant language) * Inability to install the device (even with assistance) allowing at least 6 months of data capture by the end of the study. * Patients with severe aortic stenosis or awaiting a heart procedure or surgery * Patient with end stage renal disease (eGFR \<20) * Pregnancy or lack of contraceptive measures if of child-bearing potential

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Buckinghamshire Healthcare NHS Trust

    RECRUITING

    Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom

  • Chilwell Valley and Meadows Practice

    RECRUITING

    Nottingham, NG9 6DX, United Kingdom

  • Croydon Health Services NHS Trust

    RECRUITING

    Croydon, Greater London, CR7 7YE, United Kingdom

  • Hertfordshire Community NHS Trust

    RECRUITING

    Welwyn Garden City, Hertfordshire, AL7 1BW, United Kingdom

  • Holderness Health

    RECRUITING

    Patrington, Hull, HU120PH, United Kingdom

  • Hull University Teaching Hospitals NHS Trust

    NOT_YET_RECRUITING

    Hull, HU3 2JZ, United Kingdom

  • Kent Community Health NHS Foundation Trust

    RECRUITING

    Ashford, Kent, TN25 4AZ, United Kingdom

  • Lincolnshire Community Health Services NHS Trust

    RECRUITING

    Lincoln, Lincolnshire, LN5 7JH, United Kingdom

  • Livewell Southwest

    NOT_YET_RECRUITING

    Plymouth, PL6 5DH, United Kingdom

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Milton Keynes University Hospital NHS Foundation Trust

    RECRUITING

    Milton Keynes, MK6 5LD, United Kingdom

  • North Tees & Hartlepool NHS Foundation Trust

    RECRUITING

    Hardwick, Stockton-on-Tees, TS19 8PE, United Kingdom

  • Princess of Wales Hospital

    RECRUITING

    Bridgend, CF31 1RQ, United Kingdom

  • Queen Elizabeth University Hospital (NHS Greater Glasglow & Clyde)

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • Royal Glamorgan Hospital

    RECRUITING

    Pont-y-clun, CF72 8XR, United Kingdom

  • St George's Hospital

    RECRUITING

    London, SW17 0QT, United Kingdom

  • Ulster Hospital

    NOT_YET_RECRUITING

    Belfast, BT16 1RH, United Kingdom

  • Walsall Manor Hospital

    RECRUITING

    Walsall, WS2 9PS, United Kingdom

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