Leg heat therapy for improving heart function in patients with preserved ejection fraction
Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)
This study is testing if a new leg heat therapy can help people with heart failure feel stronger and exercise better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University Academic / other |
| Locations | 2 sites (Indianapolis, Indiana and 1 other locations) |
| Trial ID | NCT06388226 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include men and women over 18 years with a confirmed diagnosis of HFpEF and stable medical treatment.
Not a fit: Patients who have been recently hospitalized or have unstable cardiac conditions may not benefit from this study.
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 performed: While this approach is novel, similar studies exploring non-pharmacological interventions for HFpEF have shown promising results.
Eligibility criteria
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 this trial is running
Indianapolis, Indiana and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.