Leg heat therapy shows promise for heart failure patients
NCT ID NCT06388226
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether daily leg heat therapy can help people with heart failure with preserved ejection fraction (HFpEF) exercise longer and feel better. Participants wear water-circulating trousers heated to 42°C for 90 minutes each day at home. The goal is to see if this improves muscle function and exercise tolerance compared to a sham treatment. The study enrolls 90 adults aged 18 and older with a confirmed HFpEF diagnosis.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Leg heat therapy using water-circulating trousers heated to 42°C
- What this could lead to
- If it works, this could offer a simple, home-based way to improve exercise capacity and quality of life for people with heart failure with preserved ejection fraction.
- What could go wrong
- This is a small pilot study with only 90 participants, so results may not apply to everyone. The treatment is non-invasive and low-risk, but it may not provide meaningful improvement over the sham therapy.
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
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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
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About 90 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Men and women older than 18 years * Established diagnosis of heart failure with preserved ejection fraction (HFpEF) including left ventricular ejection fraction (LVEF) ≥50% as evidenced by Doppler echocardiography and/or ratio of the early mitral inflow velocity (E) to septal tissue Doppler velocity (e') \>8 and at least 1 other sign of chronically elevated filling pressures, including an enlarged left atrium (left atrial volume index \>34 mL/m2), an elevated N-terminal pro-brain natriuretic peptide (NT-pro-BNP) level within the past year, long-term loop diuretic use for control of symptoms, or elevated filling pressures (mean pulmonary capillary wedge pressure \>12 mmHg) on prior cardiac catheterization * Stable medical treatment Exclusion Criteria: * Recent hospitalization (within the previous 1 month) * Unstable angina and/or uncontrolled cardiac arrhythmia causing symptoms or hemodynamic compromise (including severe bradycardia or tachycardia, sick sinus syndrome, or multifocal premature ventricular contractions) * Presence of any clinical condition that makes the patient unsuitable to participate in the trial, e.g., significant ischemic or valvular heart disease, cor pulmonale, unstable coronary artery disease, primary renal (e.g., estimated glomerular filtration rate (eGFR) \<25 mL/min/1.73 m2) or hepatic disease (e.g., aspartate aminotransferase and alanine aminotransferase levels \>3.0 times the upper limit of the normal range), pulmonary, neuromuscular, orthopedic disorders, among others * Inability to exercise on the treadmill * Inability to provide informed consent * Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse) * Any contraindication to heat therapy and/or inability to fit into water-circulating trousers * Impaired thermal sensation in the leg
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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IU Health Methodist
RECRUITINGIndianapolis, Indiana, 46202, United States
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IU Health University Hospital
RECRUITINGIndianapolis, Indiana, 46202, United States
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