Exercise Training in Patients With Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
研究概览
简要总结
Exercise training (ET) is highly beneficial in heart failure patients and has been suggested to confer significant symptomatic and functional improvements in patients with diastolic dysfunction. Accordingly, the aim of this study was to examine the safety, feasibility of a structured ET program in symptomatic HCM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •Hypertrophic Cardiomyopathy
- •Maximal left ventricular wall thickness > 20 mm
排除标准
- •Severe non-cardiac limitations of functional capacity such as neurological illness, lung disease, peripheral vascular or orthopedic problem, etc.
- •Patients state post resuscitation for malignant ventricular arrhythmia.
- •History of effort induced syncope, complex ventricular arrhythmia or atrial fibrillation.
- •An exercise-induced decrease in blood pressure
- •Severe left ventricular outflow obstruction defined as resting outflow gradient > 50 mmHg on maximal therapy
- •Atrial fibrillation with a poorly controlled ventricular response
- •Advanced hypokinetic stage of HCM defined as LVEF < 40%
- •Congestive heart failure of angina FC IV according to NYHA or CCS respectively.
结局指标
主要结局
Functional capacity improvement as determined by the degree of percent change in VO2 MAX following structured exercise rehabilitation
时间窗: 6 months
End point to be assessed by cardiopulmonary testing are pre- and post exercise training improvement as expressed by the changes in : VO2 MAX, exercise duration, duration to ventilatory threshold(VT).
Safety of exercise training in patients with symptomatic hypertrophic cardiomyopathy
时间窗: 12 months
Safety endpoonts: 1) Clinicaly significant arrhythmia during exercise training 2)MACE during follow-up period (ACS, Stroke or Death) 3)Exercise Related Injury 4) Episodes of syncope
次要结局
- Secondary Endpoints:(12 months)
研究者
Dr. Michael Arad
MD
Sheba Medical Center