Exercise Intolerance in Heart Failure: the Role of Altered Cardiac and Skeletal Muscle Energetics
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Skeletal muscle mitochondrial function
研究概览
简要总结
The investigators are studying whether metabolic abnormalities in cardiac and skeletal muscle in patients with heart failure with preserved ejection fraction (HFpEF) are associated with debilitating exercise intolerance.
详细描述
This research is being done to better understand why patients with heart failure have difficulty exercising and performing some activities of daily living. Heart muscle and skeletal muscle (in the legs and arms) depend on normal metabolism (the conversion of foods to chemical fuel) to function properly. Investigators will measure metabolites in the heart and leg muscles, including the levels of high energy phosphates and lipids (fats) using magnetic resonance (MR) techniques. High-energy phosphates serve as a source of energy, which is used by the heart and skeletal muscle for contraction. Magnetic resonance uses magnetic fields to measure the levels of these substances.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of either gender who are greater than 21 years of age (no upper age limit),
- •Permission of patient's clinical attending physician,
- •Previous clinical diagnosis of HF with current New York Heart Association (NYHA) Class II-III symptoms for at least 1 month,
- •Left ventricular ejection fraction (EF) >50% by echocardiography, MRI, CT or x-ray or nuclear ventriculography within prior 12 months,
- •Stable medical therapy for at least 30 days (no addition or removal or major (>100%) dose change of Renin-Angiotensin-Aldosterone System (RAAS) antagonists, beta-blockers, or calcium channel blockers for hypertension).
排除标准
- •Unable to understand the risks, benefits, and alternatives of participation and give meaningful consent,
- •Contraindications to MRI such as implanted metallic objects (pre-existing cardiac pacemakers, cerebral clips) or indwelling metallic projectiles,
- •Significant valvular abnormalities,
- •Pregnant women (women of childbearing potential will undergo blood or urine pregnancy testing),
- •History of clinical CAD or significant epicardial coronary disease (>50% stenosis) in major coronary artery by x-ray or CT angiography unless (a) the patient underwent prior successful revascularization with percutaneous coronary angioplasty within the prior three years and (b) there are no residual lesions of >50% on the most recent coronary angiographic study.
- •History of infiltrative cardiomyopathy or constrictive pericarditis,
- •Cor pulmonale,
- •Significant pulmonary disease,
- •Estimated glomerular filtration rate (eGFR) <20ml/min,
- •Any condition other than HF which could limit the ability to perform a 6MW or cardiopulmonary exercise test (CPET) test (e.g., critical peripheral vascular disease, significant orthopedic or neurological conditions),
- •Any diseases other than HF which are likely to significantly alter the patient's global perception of status or quality of life over a period of 6 months.
- •Significant peripheral vascular disease
研究组 & 干预措施
Hypertensive Subjects
Participants with Hypertension
HFpEF
Participants with Heart Failure with Preserved Ejection Fraction
HFrEF
Participants with Heart Failure with Reduced Ejection Fraction
Healthy Subjects
Participants without heart failure and without commodities
结局指标
主要结局
Skeletal muscle mitochondrial function
时间窗: Baseline
Maximal oxidative capacity of leg muscle measured by 31P Magnetic Resonance Spectroscopy (MRS)
Skeletal muscle energetic decline during exercise
时间窗: Baseline
Creatine phosphate rate of decline (umol/g/min) during plantar flexion exercise measured by 31P MRS
Cardiac muscle energetics
时间窗: Baseline
Cardiac muscle phosphocreatine (PCr)/ adenosine triphosphate (ATP) and creatine kinase(CK) flux (umol/g/s) measured by 31P MRS
次要结局
- Cardiopulmonary exercise testing (CPET)(Six months)
- Six minute walk test(Six months)
- Clinical heart failure outcome as assessed by time to cardiovascular death(Two years)
- Clinical heart failure outcome as assessed by overall mortality(Two years)
- Clinical heart failure outcome as assessed by number of hospitalizations(Two years)