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RECRUITING
NCT06388226
NA

Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Sponsor: Indiana University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-08-15

Completion Date

2026-08-31

Last Updated

2025-11-17

Healthy Volunteers

No

Interventions

DEVICE

Leg 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.

DEVICE

Leg 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.

Locations (2)

IU Health Methodist

Indianapolis, Indiana, United States

IU Health University Hospital

Indianapolis, Indiana, United States