Leg heat therapy for improving heart function in patients with preserved ejection fraction
Official title: Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)
Run by Indiana University · NCT06388226 · Data updated 2026-11-12
This study is testing if a new leg heat therapy can help people with heart failure feel stronger and exercise better.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Status | Recruiting |
| Started | August 15, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT06388226 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include men and women over 18 years with a confirmed diagnosis of HFpEF and stable medical treatment.
✕Probably not a fit
Patients who have been recently hospitalized or have unstable cardiac conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot study aims to evaluate the effectiveness of leg heat therapy (HT) in enhancing skeletal muscle function and physical capacity in patients diagnosed with heart failure with preserved ejection fraction (HFpEF). The central hypothesis is that HT will improve microvascular blood flow and oxygenation in skeletal muscles, leading to better exercise tolerance compared to a control group receiving sham therapy. Participants will undergo home-based HT to assess its impact on their exercise capacity and overall physical performance.
Why it matters
Potential benefit: If successful, this therapy could significantly improve the physical capabilities and quality of life for patients suffering from HFpEF.
How similar studies have gone: While this approach is novel, similar studies exploring non-pharmacological interventions for HFpEF have shown promising results.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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IU Health Methodist
Indianapolis, Indiana, United States Recruiting -
IU Health University Hospital
Indianapolis, Indiana, United States Recruiting
Study contacts
- Study coordinator: Doris Muriathiri, MPH, CCRP
- Email: dmuriath@iu.edu
- Phone: 317-274-0903
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Remote rehabilitation for HFpEF patients using telerehabilitation
A home-based telerehabilitation program is being tested to see if it is safe and helpful for people with heart failure with preserved ejection fraction.
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EDG-15400 in adults with HFpEF: a phase 2 study
This phase 2 study tests different doses of EDG-15400 against placebo in adults with HFpEF to see if it is safe and tolerable.
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Incretin therapy with tirzepatide for obesity-related HFpEF
A 15-month study will test whether tirzepatide helps people with obesity and HFpEF by reducing plasma volume.
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Boosted exercise with group coaching for HFpEF
This trial tests a blended, guided exercise program with group coaching and remote monitoring to see if it helps older adults with HFpEF improve activity and health at a lower cost.
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Exercise cardiac MRI for heart failure with preserved ejection fraction
This study will try low-field exercise cardiac MRI to see if it can diagnose, describe, and predict risk in people with HFpEF compared with those who have non-cardiac breathlessness and healthy volunteers.
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HRS-1893 for heart failure with preserved ejection fraction
This trial will test whether HRS-1893 is safe and tolerable in adults aged 40 and older who have heart failure with preserved ejection fraction.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.