Back to search results

Leg Heat Therapy for Heart Failure with Preserved Ejection Fraction

This study is exploring whether leg heat therapy can improve how well people with heart failure with preserved ejection fraction (HFpEF) can exercise. HFpEF means your heart pumps blood normally, but it's stiff and doesn't fill properly. You would receive either leg heat therapy (warm water circulated through trousers at 42ºC) or leg sham therapy (cooler water at 33ºC). Researchers will measure how long you can exercise on a treadmill to see if the heat therapy helps. To join, you must be over 18 and have a confirmed diagnosis of HFpEF. The study is currently unclear on its recruitment status and plans to enroll 90 participants.

Study design
This is an interventional study planning to enroll 90 participants. It compares leg heat therapy to a sham therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, change in time to exhaustion during treadmill exercise, is measured at baseline and at a 2-month follow-up.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06388226

Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Recruiting
NAAges 18+InterventionalTreatment
Indiana University
~90 participants
Updated 2025-11-17 on ClinicalTrials.gov
What's tested:Leg heat therapyLeg sham therapy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in time to exhaustion during treadmill exercise
Measured over Baseline to 2-month follow-up

Conditions

Heart Failure With Preserved Ejection Fraction

Explore related trials

Heart failure with normal ejection fraction

Where it's being run

2 sites across 1 states
Indiana2

Who to contact

Doris Muriathiri, MPH, CCRP
[email protected]
317-274-0903
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in time to exhaustion during treadmill exerciseBaseline to 2-month follow-up

    The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the time to exhaustion during treadmill exercise testing at 2-month follow-up compared to a sham treatment.