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Life sciences · Interventional Study
ClinicalTrials.gov · October 28, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06388226). This is a study registration, not published results. Lead sponsor: Indiana University. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Heart Failure With Preserved Ejection Fraction. Interventions: DEVICE: Leg heat therapy; DEVICE: Leg sham therapy. Primary outcome measures: Change in time to exhaustion during treadmill exercise , Baseline to 2-month follow-up. Brief 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.