Leg Heat Therapy to Improve Functional Performance in Heart Failure With Preserved Ejection Fraction (HFpEF)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Change in time to exhaustion during treadmill exercise
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in time to exhaustion during treadmill exercise
时间窗: 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.
次要结局
- Change in maximal pulmonary oxygen uptake during treadmill exercise(Baseline to 2-month follow-up)
- Change in triceps surae intramuscular fat content(Baseline to 2-month follow-up)
- Change in triceps surae microvascular oxygenation during treadmill exercise(Baseline to 2-month follow-up)
- Change in systolic blood pressure(Baseline to 2-month follow-up)
- Change in diastolic blood pressure(Baseline to 2-month follow-up)
- Change in triceps surae microvascular oxygenation during reactive hyperemia(Baseline to 2-month follow-up)
- Change in triceps surae volume(Baseline to 2-month follow-up)
- Change in the time constant for phosphocreatine recovery after dynamic exercise(Baseline to 2-month follow-up)
- Change in maximal plantar flexor strength(Baseline to 2-month follow-up)
- Change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score(Baseline to 2-month follow-up)
研究者
Onyedika Ilonze
Assistant Professor of Clinical Medicine
Indiana University