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Behavioural Intervention

Leg Heat Therapy for Heart Failure

N/A
Recruiting
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Established diagnosis of heart failure with preserved ejection fraction (HFpEF) including left ventricular ejection fraction (LVEF) ≥50% as evidenced by Doppler echocardiography and/or ratio of the early mitral inflow velocity (E) to septal tissue Doppler velocity (e') >8 and at least 1 other sign of chronically elevated filling pressures, including an enlarged left atrium (left atrial volume index >34 mL/m2), an elevated N-terminal pro-brain natriuretic peptide (NT-pro-BNP) level within the past year, long-term loop diuretic use for control of symptoms, or elevated filling pressures (mean pulmonary capillary wedge pressure >12 mmHg) on prior cardiac catheterization
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2-month follow-up
Awards & highlights

Summary

This trial aims to investigate whether a home-based heat therapy can help improve the muscle function and physical capacity of patients with heart failure with preserved ejection fraction (HFpEF). The study hypothesis is that

Who is the study for?
This trial is for men and women over 18 with heart failure where the heart's main pumping chamber still pumps well (HFpEF). They must have had certain tests showing this condition, like an echocardiogram or elevated NT-pro-BNP levels, and be on stable medications.
What is being tested?
The study is testing leg heat therapy to see if it improves muscle function and exercise ability in patients with HFpEF. Participants will receive either actual heat therapy or a sham (fake) treatment as a control to compare results.
What are the potential side effects?
While specific side effects are not detailed here, leg heat therapy may cause discomfort, skin irritation, or burns if not properly monitored. The sham treatment should have no side effects since it mimics the real treatment without applying actual heat.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have heart failure with a normal pump function confirmed by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in time to exhaustion during treadmill exercise
Secondary study objectives
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
Change in diastolic blood pressure
Change in maximal plantar flexor strength
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Heat therapyExperimental Treatment1 Intervention
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.
Group II: Sham controlPlacebo Group1 Intervention
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.

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,125 Total Patients Enrolled
18 Trials studying Heart Failure
3,773 Patients Enrolled for Heart Failure
Purdue UniversityOTHER
228 Previous Clinical Trials
72,780 Total Patients Enrolled
1 Trials studying Heart Failure
314 Patients Enrolled for Heart Failure
~60 spots leftby Jul 2026
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