NCT06388226

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure With Preserved Ejection Fraction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-15
• Primary completion: 2026-08-20
• Completion: 2026-08-31
• First posted: 2024-04-29
• Last updated: 2025-11-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study