Heart Failure With Preserved Ejection FractionNCT06388226
Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
A study testing Leg heat therapy in people with Heart Failure With Preserved Ejection Fraction, run by Indiana University at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- Leg heat therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Aug 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women older than 18 years
- 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
- Stable medical treatment
Who cannot join
- Recent hospitalization (within the previous 1 month)
- Unstable angina and/or uncontrolled cardiac arrhythmia causing symptoms or hemodynamic compromise (including severe bradycardia or tachycardia, sick sinus syndrome, or multifocal premature ventricular contractions)
- Presence of any clinical condition that makes the patient unsuitable to participate in the trial, e.g., significant ischemic or valvular heart disease, cor pulmonale, unstable coronary artery disease, primary renal (e.g., estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2) or hepatic disease (e.g., aspartate aminotransferase and alanine aminotransferase levels >3.0 times the upper limit of the normal range), pulmonary, neuromuscular, orthopedic disorders, among others
- Inability to exercise on the treadmill
- Inability to provide informed consent
- Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse)
- Any contraindication to heat therapy and/or inability to fit into water-circulating trousers
- Impaired thermal sensation in the leg
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
IU Health Methodist
Indianapolis, Indiana, 46202
Doris Muriathiri, MPH, CCRP, 317-274-0903, dmuriath@iu.edu
- Recruiting
IU Health University Hospital
Indianapolis, Indiana, 46202
Doris Muriathiri, MPH, CCRP, 317-274-0908, dmuriath@iu.edu
About this study
Official title: Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)
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.
- Being tested
- Leg heat therapy, Leg sham therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg heat therapyDevice
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 therapyDevice
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 group | Role | What they receive |
|---|---|---|
| Heat therapy | Experimental | 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. Receives: Device: Leg heat therapy |
| Sham control | Sham comparator | 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. Receives: Device: Leg sham therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time to exhaustion during treadmill exercise
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the time to exhaustion during treadmill exercise testing at 2-month follow-up compared to a sham treatment.
Measured: Baseline to 2-month follow-up
Secondary outcomes (10)
Change in maximal pulmonary oxygen uptake during treadmill exercise
Maximal pulmonary oxygen uptake (VO2max) will be evaluated during treadmill exercise testing. The investigators will determine whether leg heat therapy improves VO2max at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in triceps surae microvascular oxygenation during treadmill exercise
Microvascular oxygenation will be assessed using near-infrared spectroscopy (NIRS) during treadmill exercise testing. The investigators will determine whether leg heat therapy improves muscle microvascular oxygenation at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in systolic blood pressure
The systolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves systolic blood pressure at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in diastolic blood pressure
The diastolic blood pressure will be measured in triplicate using a blood pressure monitor. The investigators will determine whether leg heat therapy improves blood pressure at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
Health-related quality of life will then be assessed via the MLHFQ, which is a validated, self-administered, 21-item disease-specific instrument for patients with heart failure. Items are scored in a 6-point Likert scale (0 to 5) and reflect physical, emotional and socioeconomic status during the past 4 weeks. The questionnaire is scored by summation of all 21 responses (with higher scores indicating poorer quality of life).
Measured: Baseline to 2-month follow-up
Change in triceps surae microvascular oxygenation during reactive hyperemia
Microvascular oxygenation will be assessed using near-infrared spectroscopy (NIRS) during reactive hyperemia. The investigators will determine whether leg heat therapy improves muscle microvascular oxygenation at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in triceps surae volume
The volume of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy improves calf muscle volume at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in triceps surae intramuscular fat content
The intramuscular fat content of calf muscles will be determined using magnetic resonance (MR) images. The investigators will determine whether leg heat therapy reduces intramuscular fat content at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in the time constant for phosphocreatine recovery after dynamic exercise
Magnetic resonance spectroscopy tuned to phosphorous (31PMRS) will be used to measure the time constant for PCr recovery (τ) after dynamic planar flexion exercise. The investigators will determine whether leg heat therapy reduces the time constant for PCr recovery at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Change in maximal plantar flexor strength
The maximal voluntary contraction (MVC) strength of the plantar flexor muscles will be assessed using an MR-compatible ergometer. Participants will be asked to perform three plantar-flexor MVCs separated by a one-minute rest period. The MVC torque will be considered the highest peak torque value measured over the three trials. The investigators will determine whether leg heat therapy improves maximal plantar flexor strength at 2-month follow-up compared to the sham treatment.
Measured: Baseline to 2-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start15 Aug 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Purdue University
- Responsible party
- Principal investigator, Onyedika Ilonze, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388226
- Sponsor's protocol ID
- IRB # 16143
- Status last verified
- Oct 2026
- First submitted
- 24 Apr 2024
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)
- ClinicalTrials.gov ID
- NCT06388226
- Acronym / sponsor ID
- IRB # 16143
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Purdue University
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heat therapy | Experimental | Device: Leg heat therapyPatients 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 control | Sham comparator | Device: Leg sham therapyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women older than 18 years
- 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
- Stable medical treatment
Key exclusion criteria (8 listed)
- Recent hospitalization (within the previous 1 month)
- Unstable angina and/or uncontrolled cardiac arrhythmia causing symptoms or hemodynamic compromise (including severe bradycardia or tachycardia, sick sinus syndrome, or multifocal premature ventricular contractions)
- Presence of any clinical condition that makes the patient unsuitable to participate in the trial, e.g., significant ischemic or valvular heart disease, cor pulmonale, unstable coronary artery disease, primary renal (e.g., estimated glomerular filtration rate (eGFR) <25 mL/min/1.73 m2) or hepatic disease (e.g., aspartate aminotransferase and alanine aminotransferase levels >3.0 times the upper limit of the normal range), pulmonary, neuromuscular, orthopedic disorders, among others
- Inability to exercise on the treadmill
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Leg heat therapyA 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 | Heat therapy |
| Leg sham therapyA 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. | Device | Sham control |
Primary outcome
Change in time to exhaustion during treadmill exercise
Time frame: Baseline to 2-month follow-up
The investigators will determine whether daily leg heat therapy for 90 min using water-circulating trousers perfused with water heated to 42ºC improves the time to exhaustion during treadmill exercise testing at 2-month follow-up compared to a sham treatment.
10 secondary outcomes
Change in maximal pulmonary oxygen uptake during treadmill exercise
Time frame: Baseline to 2-month follow-up
Change in triceps surae microvascular oxygenation during treadmill exercise
Time frame: Baseline to 2-month follow-up
Change in systolic blood pressure
Time frame: Baseline to 2-month follow-up
Change in diastolic blood pressure
Time frame: Baseline to 2-month follow-up
Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
Time frame: Baseline to 2-month follow-up
Change in triceps surae microvascular oxygenation during reactive hyperemia
Time frame: Baseline to 2-month follow-up
Change in triceps surae volume
Time frame: Baseline to 2-month follow-up
Change in triceps surae intramuscular fat content
Time frame: Baseline to 2-month follow-up
Change in the time constant for phosphocreatine recovery after dynamic exercise
Time frame: Baseline to 2-month follow-up
Change in maximal plantar flexor strength
Time frame: Baseline to 2-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg heat therapy in people with Heart Failure With Preserved Ejection Fraction, run by Indiana University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Doris Muriathiri, MPH, CCRP (317-274-0903, dmuriath@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time to exhaustion during treadmill exercise (time frame: Baseline to 2-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.