The EXerCise traIning To rEcovery in HCM Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in V O2 max
研究概览
简要总结
The EXCITE-HCM study is a randomized, controlled, blinded clinical trial designed to evaluate the effect of moderate intensity exercise training versus usual physicial activity on the improvement of HCM-related symptoms and cardiac function. About 70 participants will be recruited and randomized on a 1:1 ratio to either moderate intensity training or usual physicial activity interventions. Patients will be followed during a period of 24 weeks and assesesments as physical examination, questionnaires, 12 lead ecg's, biomarker levels, echocardiogram, Cardiac Magnetic resonance, PET and CPET will be performed to evaluate their response to the intervention.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 to 80 years of age with diagnosis of hypertrophic cardiomyopathy1 defined by left ventricular hypertrophy with end-diastolic wall thickness 15 mm or greater on 2D echocardiography in the absence of other primary causes of left ventricular hypertrophy or wall thickness between 13 and 15 mm in the presence of other features suggestive of hypertrophic cardiomyopathy, such as systolic anterior motion of the mitral valve leaflets, family history of hypertrophic cardiomyopathy, or positive genetic test result.
- •Left ventricular outflow tract gradient <30 mmHg at rest and with provocation.
- •Left ventricular ejection fraction ≥ 50% by biplane Simpson's method.
- •Access to exercise equipment at home or at a fitness center.
- •Ability to complete study related testing including online surveys and smart phone use
- •Ability to perform 24 weeks of exercise training
排除标准
- •History of exercise-induced syncope or ventricular arrhythmias
- •LVOT obstruction being evaluated for septal reduction therapy; less than 3 months after
- •History of septal reduction therapy - surgery or ablation
- •History of ICD placement in the previous 3 months
- •History of hypotensive response with exercise testing (>20 mm Hg decrease of systolic blood pressure from baseline blood pressure or an initial increase in systolic blood pressure followed by a decrease of systolic blood pressure >20 mm Hg)
- •Clinical decompensation in the previous 3 months, defined as New York Heart Association class IV congestive heart failure symptoms or Canadian Cardiovascular Society class IV angina symptoms
- •Left ventricular ejection fraction less than 50% by echocardiography
- •Life expectancy less than 12 months
- •Pregnant or planned pregnancy
- •Inability to exercise owing to any medical or other limitations
- •Unwillingness to refrain from competitive sports, burst activity, or heavy isometric exercise for the duration of the study, if assigned to the non-exercise group.
研究组 & 干预措施
Moderate Intensity Exercise arm
All patients randomized to the exercise training group will undergo a single supervised in-hospital exercise session that includes an exercise consultation with a certified exercise physiologist. Following that they will exercise at-home with video supervision 3 times a week for a period of 24 weeks.
干预措施: Moderate Intensity Exercise Program (Behavioral)
Usual physical activity arm
Patients randomized to the usual-activity group will be instructed to continue their current activity without initiating or intensifying any existing exercise regimens for the duration of the study
结局指标
主要结局
Change in V O2 max
时间窗: Baseline and 24 weeks
Change in peak oxygen consumption (V O2 max: mL/kg/min) by CPET
Change in peak VO2 %
时间窗: Baseline and 24 weeks
Change in peak VO2 % predicted (%) by CPET
次要结局
- Change in Myocardial Work(Baseline and 24 weeks)
- Change in Myocardial Systolic Strain(Baseline and 24 Weeks)