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NCT06388226Recruiting

Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)

Source: ClinicalTrials.gov · Last updated 28 Oct 2026

Brief summary (registry, in English)

The objective of this pilot study is to establish evidence to support the validity of HT in improving skeletal muscle function and physical capacity of patients with HFpEF. Our central hypothesis is that HT treatment will lead to improvements in skeletal muscle and microvascular function compared to a control intervention. As a result, we anticipate that patients treated with HT will demonstrate improved skeletal muscle microvascular blood flow and oxygenation resulting in enhanced exercise tolerance. To explore this hypothesis, we propose the following specific aim: Explore the effects of home-based HT on exercise tolerance in patients with HFpEF.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
90 (estimated)
First submitted
24 Apr 2024
Start date
15 Aug 2024
Primary completion date
31 Aug 2027
Lead sponsor
Indiana University
NCT number
NCT06388226

What you commit to

  • Study type: Interventional
  • Planned participants: 90
  • From 15 Aug 2024 to the primary completion date, 31 Aug 2027
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent hospitalization (within the previous 1 month)
  • 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

Other illness

  • 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)

Lab values

  • 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

Other

  • Inability to exercise on the treadmill
  • Inability to provide informed consent
  • Impaired thermal sensation in the leg

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
IU Health University Hospital
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting
IU Health Methodist
Coordinator of this site? Confirm its status
IndianapolisUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.