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Could inflatable leg boots help heart failure patients?

NCT ID NCT07377019

Symptom relief Sponsor: Odense University Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether pulsatile compression boots, which rhythmically squeeze the legs, can help patients hospitalized with acute heart failure and leg swelling. The boots aim to move fluid out of the legs, improve circulation, and support heart and kidney function. One hundred participants will receive either standard diuretic treatment plus the boots or standard care alone. The main goal is to see if the boots safely reduce pressure in the heart's arteries.

What this could mean

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

Active substance
Pulsatile compression boots (a device that inflates and deflates chambers around the legs to improve circulation)
What this could lead to
If it works, this could offer a safe, non-drug way to help heart failure patients clear fluid from their legs and improve heart and kidney function during hospital stays.
What could go wrong
This is a small, early-stage trial with only 100 participants, so results may not apply to all patients. The device is added to standard care, so any benefit may be modest, and there is a risk it may not improve outcomes.

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 100 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Capable of giving written informed consent * Inclusion within 24 hours from admission * Bilateral LE edema - defined as: Pitting edema scale \> 1, bilaterally * Initial IV diuretic treatment Evidence of heart failure - at least one of the following: 1. Heart failure with reduced ejection fraction (HFrEF): * Signs and/or symptoms of HF * Left ventricular ejection fraction (LVEF) ≤ 40% 2. Heart failure with mildly reduced ejection fraction (HFmrEF): * Signs and/or symptoms of HF * LVEF 41 - 49% 3. Heart failure with preserved ejection fraction (HFpEF): * Signs and/or symptoms of HF * LVEF ≥ 50 % * Evidence of structural heart disease (Left atrial enlargement or left ventricular hypertrophy) * NT-proBNP \> 300pg/mL for patients without ongoing atrial fibrillation/flutter, and NT-proBNP \> 600 pg/mL for patients with ongoing atrial fibrillation/flutter. Evidence of elevated pulmonary artery pressure - at least one of the following: * Systolic pulmonary artery pressure (sPAP) \> 35 mmHg * Tricuspid regurgitation gradient (TRG) \> 30 mmHg * Severe tricuspid regurgitation and VCI \> 20 mm. Additional echocardiographic criteria: \- Left atrial end-systolic volume index \> 34 mL/m2 Exclusion Criteria: * Pregnancy * Life expectancy less than 1 year for any reason * Expected hospital stay less than 1 day * New York Heart Association classification (NYHA) class IV * LVEF \< 20% * Diastolic left ventricular diameter \> 70 mm * Known history or symptoms of peripheral arterial disease (Intermittent claudication or brachial-ankle index with value \< 0,9) * Significant leg wounds or infections * Deep venous thrombosis (DVT) * Need for treatment with inotropes or vasopressors * Permanent dialysis * Manifest acute kidney injury with oliguria * Current high-pressure pulmonary edema

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Conditions

The condition(s) this trial relates to.

cardio-renal syndrome congestive heart failure heart failure

As listed by the trial registrant

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

Acute decompensated heart failure (ADHF)

How to take part

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

  1. The places running it

    1 site. 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

  • Cardiovascular Research Unit. Odense University Hospital, Svendborg.

    Svendborg, 5700, Denmark

More trials for these conditions

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