Clinical trial NCT06388226: Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction
Official title: Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure With Preserved Ejection Fraction
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Purdue University
First posted: 2024-04-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in time to exhaustion during treadmill exercise
timeFrame: Baseline to 2-month follow-up
Secondary outcomes:
measure: Change in maximal pulmonary oxygen uptake during treadmill exercise
timeFrame: Baseline to 2-month follow-up
measure: Change in triceps surae microvascular oxygenation during treadmill exercise
timeFrame: Baseline to 2-month follow-up
measure: Change in systolic blood pressure
timeFrame: Baseline to 2-month follow-up
measure: Change in diastolic blood pressure
timeFrame: Baseline to 2-month follow-up
measure: Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score
timeFrame: Baseline to 2-month follow-up
measure: Change in triceps surae microvascular oxygenation during reactive hyperemia
timeFrame: Baseline to 2-month follow-up
measure: Change in triceps surae volume
timeFrame: Baseline to 2-month follow-up
measure: Change in triceps surae intramuscular fat content
timeFrame: Baseline to 2-month follow-up
measure: Change in the time constant for phosphocreatine recovery after dynamic exercise
timeFrame: Baseline to 2-month follow-up
measure: Change in maximal plantar flexor strength
timeFrame: Baseline to 2-month follow-up
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: IU Health Methodist
state: Indiana
city: Indianapolis
country: United States
facility: IU Health University Hospital
state: Indiana
Study officials:
References: