Leg Heat Therapy in Heart Failure With Preserved Ejection Fraction

Официальное название

Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)

Обзор

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.

Вмешательства

• Устройство Leg heat therapy
  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.
• Устройство Leg sham therapy
  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.

Первичные конечные точки

• Change in time to exhaustion during treadmill exercise [Срок оценки: Baseline to 2-month follow-up]

Вторичные конечные точки (10)

• Change in maximal pulmonary oxygen uptake during treadmill exercise [Срок оценки: Baseline to 2-month follow-up]
• Change in triceps surae microvascular oxygenation during treadmill exercise [Срок оценки: Baseline to 2-month follow-up]
• Change in systolic blood pressure [Срок оценки: Baseline to 2-month follow-up]
• Change in diastolic blood pressure [Срок оценки: Baseline to 2-month follow-up]
• Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score [Срок оценки: Baseline to 2-month follow-up]
• Change in triceps surae microvascular oxygenation during reactive hyperemia [Срок оценки: Baseline to 2-month follow-up]
• Change in triceps surae volume [Срок оценки: Baseline to 2-month follow-up]
• Change in triceps surae intramuscular fat content [Срок оценки: Baseline to 2-month follow-up]
• Change in the time constant for phosphocreatine recovery after dynamic exercise [Срок оценки: Baseline to 2-month follow-up]
• Change in maximal plantar flexor strength [Срок оценки: Baseline to 2-month follow-up]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 2 центра

• IU Health Methodist — Indianapolis
• IU Health University Hospital — Indianapolis

Идентификаторы

NCT: NCT06388226 · IRB # 16143

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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