Actively Recruiting
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Led by Indiana University · Updated on 2025-11-17
90
Participants Needed
2
Research Sites
106 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
P
Purdue University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women older than 18 years
- Established diagnosis of heart failure with preserved ejection fraction (HFpEF) with left ventricular ejection fraction ≥50% confirmed by echocardiography and/or specific heart function measurements
- At least one additional sign of chronically elevated heart filling pressures such as enlarged left atrium, elevated NT-pro-BNP levels within the past year, long-term loop diuretic use, or elevated filling pressures from prior cardiac catheterization
- Stable medical treatment
You will not qualify if you...
- Recent hospitalization within the previous 1 month
- Unstable angina or uncontrolled cardiac arrhythmia causing symptoms or affecting heart function
- Significant ischemic or valvular heart disease, cor pulmonale, unstable coronary artery disease, severe kidney or liver disease, pulmonary, neuromuscular, or orthopedic disorders
- Inability to exercise on a treadmill
- Unable to provide informed consent
- Concerns about ability to comply with study procedures or follow-up, including alcohol or drug abuse
- Contraindications to heat therapy or inability to fit into water-circulating trousers
- Impaired thermal sensation in the leg
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
IU Health Methodist
Indianapolis, Indiana, United States, 46202
Actively Recruiting
2
IU Health University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
D
Doris Muriathiri, MPH, CCRP
CONTACT
D
Daniel Hirai, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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