Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Launched by INDIANA UNIVERSITY · Apr 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called heat therapy to see if it can help improve muscle function and physical ability in patients with heart failure with preserved ejection fraction (HFpEF). The researchers believe that using heat therapy may increase blood flow and oxygen delivery to the muscles, which could help patients exercise more easily and feel better overall. They are specifically looking at how effective home-based heat therapy is for improving exercise tolerance in these patients.

To participate in this trial, individuals need to be at least 18 years old and have a confirmed diagnosis of HFpEF, which means their heart can pump blood but isn’t functioning as well as it should. They should also be stable on their heart medications. However, people with certain conditions, like recent hospitalizations or severe heart problems, won't be eligible. If you join the trial, you can expect to receive heat therapy at home and participate in assessments that measure how well you can exercise. This study is currently recruiting participants, and it offers a chance to contribute to new ways of helping those with heart failure.

Gender

ALL

Eligibility 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