Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT06388226
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leg heat therapy — DEVICE
    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.
  • Leg sham therapy — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 15, 2024
Status verified
Nov 2025
Primary completion
Aug 20, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Heat therapy
    Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 42ºC. Participants will be asked to apply the therapy daily for 90 min while in the supine position.
  • Sham Comparator: Sham control
    Patients will be provided with water-circulating trousers, a water heater, and a water tank coupled to a water pump. The heater will be adjusted to warm up the water to 33ºC. Participants will be asked to apply the therapy daily for 90 min while seated or in the supine position.

Primary Outcome Measure

Change in time to exhaustion during treadmill exercise [ Time Frame: Baseline to 2-month follow-up ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
IU Health MethodistIndianapolisIndiana46202
Doris Muriathiri, MPH, CCRP
[email protected]
317-274-0903
IU Health University HospitalIndianapolisIndiana46202
Doris Muriathiri, MPH, CCRP
[email protected]
317-274-0908

Find similar trials in Indianapolis, IN

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
IU Health Methodist· Indianapolis, INIU Health University Hospital· Indianapolis, IN

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