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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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether heat therapy for the legs at home can help people with heart failure with preserved ejection fraction (HFpEF) exercise better. HFpEF is heart failure in which the heart still pumps out a normal share of blood. The study will compare heat therapy with a control treatment to see if it improves muscle function and blood flow.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men and women older than 18.
  • Have a confirmed diagnosis of HFpEF, with heart tests and other signs that meet the study’s rules.
  • Be on stable medical treatment.

Who can't join

  • Have been in the hospital within the past month.
  • Have unstable chest pain from poor heart blood flow, or an uncontrolled heartbeat problem that causes symptoms or affects blood flow.
  • Have another health condition that makes joining unsafe, such as certain heart, kidney, liver, lung, nerve, muscle, bone, or joint problems.
  • Cannot exercise on a treadmill.
  • Cannot give informed consent, meaning you cannot understand the study and agree to join.
  • May not be able to follow study steps or attend follow-up visits, including because of alcohol or drug abuse.
  • Have a medical reason to avoid heat therapy, or cannot fit into the pants that circulate water.
  • Have trouble feeling heat or cold in your leg.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (2)

IN