Will Elevated Left Ventricle Filling Pressures Decrease by a Group Exercise Program in Patients With Hypertrophic CardioMyopathy? - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change from baseline to follow-up in PCWP at 25 W
研究概览
简要总结
Aims and objectives: The primary objective of this study is to assess whether a structured exercise program improves cardiac relaxing properties in patients with hypertrophic cardiomyopathy (HCM).
Background: HCM is a hereditary disease in which the myocardium becomes thickened without an identifiable cause (other than genetic). It is the most common genetic cardiovascular disease with an estimated prevalence of 1/500 (i.e. 10.000 affected individuals in Denmark). The majority of patients with HCM suffers from shortness of breath and reduced exercise capacity due to increased left ventricular (LV) stiffness. Exercise training has been shown to improve exercise capacity and symptoms in patients with HCM, but the mechanisms responsible for this improvement are not known.
Methods and materials: The study is a randomized, single blinded, prospective, controlled clinical trial. Eighty patients are recruited from outpatient clinics in the Capital Region of Denmark. Patients are randomized in a 1:1 ratio to 12 week of moderate-intensity exercise training or usual activity level. Assessments will include right heart catheterization, echocardiography, cardiopulmonary exercise testing, blood-samples, quality of life, and, in a subgroup of patients, cardiac magnetic resonance imaging. The primary end-point is change in LV filling pressure assessed as pulmonary capillary wedge pressure at 25 W workload.
Expected outcome and perspectives: The investigators hypothesize that an exercise training program will reduce cardiac stiffness and improve symptoms in patients with HCM. Training of HCM patients has long been debated and the topic is poorly researched. The effects of exercise on hemodynamics in HCM patients are unknown and a better understanding of these mechanisms is pivotal for improving treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (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
- •≥18 years at the time of screening
- •Documented phenotypic HCM (maximal wall thickness ≥15mm, or ≥13mm in a first degree relative with a definite or likely disease causing genetic mutation (appendix 1)
- •Not exercising regularly (dedicated moderate or high-intensity exercise >1 hour weekly)
- •NYHA class I-IV.
排除标准
- •Phenocopies (i.e. syndromes, metabolic disorders (appendix 2))
- •A history of exercise induced syncope within the last year, severe angina (CCS III-IV), hemodynamically severe valvular disorders
- •Scheduled septal reduction therapy, less than 3 months after septal reduction therapy or known LVOT gradient above 30 mmHg at rest
- •Severe hypertension (Systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg).
- •Inability to exercise due to orthopedic or other non-cardiovascular limitations.
- •Changes in medication that may affect exercise capacity and/or hemodynamics (i.e. beta blockers and calcium channel blockers)
- •Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
结局指标
主要结局
Change from baseline to follow-up in PCWP at 25 W
时间窗: 12 weeks
Pulmonary capillary wedge pressure (mmHg)
次要结局
- Troponin-T(12 weeks)
- Systemic vascular resistance(12 weeks)
- NT-Pro-BNP(12 weeks)
- Workload adjusted Pulmonary capillary wedge pressure(12 weeks)
- Echocardiographic parameters(12 weeks)
- Pulmonary capillary wedge pressure(12 weeks)
- Heart rate(12 weeks)
- Blood pressure(12 weeks)
- Arterio-venous difference(12 weeks)
- Quality of life questionnaire(12 weeks)
- Exercise capacity(12 weeks)
- Cardiac index(12 weeks)
- VO2 max(12 weeks)
研究者
Helga Gudmundsdottir
MD
Bispebjerg Hospital