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Smart foot scanner could keep heart failure patients out of hospital

NCT ID NCT05193084

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device that automatically measures foot volume to help monitor fluid levels in heart failure patients. Researchers wanted to see if it could help doctors adjust diuretic treatment at home and detect early signs of fluid overload before a hospital stay. The study involved 23 patients and focused on gathering initial data to plan larger future trials.

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 foot volume measuring device)
What this could lead to
If successful, this device could help doctors adjust diuretic treatment remotely and detect fluid buildup early, potentially reducing hospital visits for heart failure patients.
What could go wrong
This is a very small, early-stage study with only 23 participants, so results may not apply to all patients. The device's accuracy and usefulness need much larger trials to confirm.

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.

Participants

23 people

The number who actually took part.

Started

Mar 2022

Finished

Jun 2023

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.

Who is studied

Patients must be aged 18 years or older with a diagnosis of heart failure at the time of signing the informed consent form and be under the care of the Heart Failure service at Manchester University NHS Foundation Trust.

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.

Work stream 1 Inclusion Criteria: 1. Patient is willing and able to provide written informed consent. 2. Diagnosis of heart failure 3. Patient with peripheral oedema requiring IV diuretics 4. Patient accepted for co-management by the MFT Heart Failure and home IV team\* * There may be some instances where the patient is under the management of the MFT HF team but attends the day unit for IVs due to capacity or other logistical considerations. These patients can also be enrolled in the evaluation. Work stream 1 Exclusion Criteria: 1. Patient has bandages to lower limbs everyday 2. Patient has an amputation of the foot 3. Patient lacks capacity to consent 4. Patient is not ambulant or unable to mobilise unaided around the house 5. Patient is of no fixed abode 6. Patient has potentially reversible cause of decompensated heart failure and is awaiting intervention (revascularisation/ valvular intervention) 7. Patient taking part in a conflicting evaluation/study that could confound the results of this evaluation by and/or impact clinical interventions and patient outcomes 8. Patient must not be pregnant, and is taking relevant birth control if of child-bearing potential\* Note that a patient not able to comply with daily weights is NOT an exclusion criteria as the Heartfelt Device should provide data for these patients despite their lack of ability to adhere to the usual monitoring protocol. \*Note that criteria (h) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (the typical age of patients is expected in an earlier evaluation was around 70 years ). Work stream 2 Inclusion Criteria: 1. Patient is willing and able to provide written informed consent. 2. Diagnosis of heart failure 3. Patient under follow up with the MFT HF service 4. Patient with a recent admission with decompensated heart failure in last 12 months OR who received home IV diuretics within the last 12-months 5. Patient has been discharged on at least furosemide 80mg or equivalent diuretic dose Work stream 2 Exclusion Criteria: 1. Patient has bandages everyday 2. Patient has an amputation of the foot 3. Patient lacks capacity to consent 4. Patient is not ambulant or unable to mobilise unaided around the house 5. Patient is of no fixed abode 6. Patient has potentially reversible cause of decompensated heart failure and is awaiting intervention (revascularisation/ valvular intervention) 7. Patient taking part in a conflicting evaluation/study that could confound the results of this evaluation by increasing clinic workload burden for that patient and/or impact clinical interventions and patient outcomes 8. Patient must not be pregnant, and is taking relevant birth control if of child-bearing potential\* Note that a patient not able to comply with daily weights is NOT an exclusion criteria as the Heartfelt Device should provide data for these patients despite their inability to use weighing scales at times. \*Note that criteria (h) has been requested by the insurance for clinical trial cover. However we do not expect participants of this study to be trying to get pregnant (the typical age of patients is expected in an earlier evaluation was around 70 years).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • The Manchester Heart Centre Manchester University NHS Foundation

    Manchester, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.