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Foot scanner could keep heart failure patients out of hospital

NCT ID NCT06334822

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This UK study tests a device that scans your feet each day to detect fluid buildup, a key sign of worsening heart failure. The goal is to catch problems early so doctors can adjust treatment and prevent hospital stays. About 186 adults with heart failure are taking part, using the device at home alongside standard care.

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 (foot volume scanner)
What this could lead to
If it works, this device could help heart failure patients avoid hospital stays by catching fluid buildup early.
What could go wrong
This is a small, early-stage trial with 186 people, so results may not apply to everyone. The device is meant to aid, not replace, standard care.

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

186 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 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: In order to be eligible to participate in this trial, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form (e-consent via website or app is acceptable). * Women or men, aged 18 years or older \[No maximum age\]. * Diagnosis of heart failure at least 3 months previously * Receiving diuretics on a daily basis * Peripheral oedema reported on at least one HF-related hospitalisation in the last 4 years (as documented in EPR). * Hospitalised for HF OR on a Virtual Ward for HF OR has received IV diuretic treatment in the last 12 months, or treated with at least 80 mg furosemide (or equivalent) orally per day. * For women of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 6 weeks after the end of the study. * Is considered by the investigator to be non-adherent OR at high risk of HF hospital readmissions. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * bandages to lower limbs every day * amputation of both feet * regular wheelchair user inside their home * bed-bound * no fixed abode * taking part in a conflicting evaluation/study that could confound the results of this evaluation and/or impact clinical interventions and participant outcomes * Pregnancy or lack of contraceptive measures if of child-bearing potential† * 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 † This exclusion criterion has been requested by the insurance provider for clinical trial cover.

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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

Contacts and locations

Locations

  • Barking, Havering and Redbridge University Hospitals NHS Trust

    London, RM1 2BA, United Kingdom

  • Croydon Health Services NHS Trust

    Croydon, London, CR7 7YE, United Kingdom

  • DR GT Hendow Surgery

    Hull, HU7 4DW, United Kingdom

  • Dr R Raut & Partnership (General Practice)

    Hull, East Riding Of Yorkshire, HU7 5DD, United Kingdom

  • James Alexander Family Practice

    Hull, United Kingdom

  • Modality East Surrey Medical Practice

    Horley, Surrey, RH6 9PT, United Kingdom

  • Modality Partnership Airedale, Wharfedale & Craven:

    Keighley, West Yorkshire, BD21 1LA, United Kingdom

  • Pillsorted Ltd

    Cambridge, CB22 3GN, United Kingdom

  • Sutton Manor Pharma Services

    Hull, HU7 4PT, United Kingdom

  • The Ridings Medical Group

    Brough, East Riding Of Yorkshire, HU15 1AY, United Kingdom

  • West Suffolk NHS Foundation Trust

    Bury St Edmunds, Suffolk, IP33 2QZ, United Kingdom

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