RecruitingNot ApplicableNCT06388226

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)

Sponsor

Indiana University

Enrollment

90 participants

Start Date

Aug 15, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether applying warm water around the legs (leg heat therapy) using a special device helps improve exercise tolerance and quality of life in people with heart failure with preserved ejection fraction (HFpEF) — a type of heart failure where the heart pumps normally but is too stiff. **You may be eligible if...** - You are 18 or older - You have been diagnosed with HFpEF (heart failure where the pumping function is preserved) - You are on stable heart failure medications **You may NOT be eligible if...** - You were hospitalized in the last month - You have unstable angina or uncontrolled heart rhythm problems - You have significant valve disease, coronary artery disease, or severe kidney or liver problems - You have conditions affecting your legs that would make heat therapy unsafe (e.g., severe peripheral artery disease, venous ulcers, skin conditions, or recent blood clots) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICELeg heat therapy

A sous vide heating immersion circulator heats up the water inside the water tank to 42ºC. A water pump circulates temperature-regulated water through the trousers.

DEVICELeg sham therapy

A sous vide heating immersion circulator heats up the water inside the water tank to 33ºC. A water pump circulates temperature-regulated water through the trousers.