Exercise Training in Grown-up Congenital Heart Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise
研究概览
简要总结
Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease.
Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.
Study design: International, multi-centre parallel randomized controlled trial.
Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III.
Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care.
Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.
详细描述
The investigators intend to submit the trial design of this study for this purpose.
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
- None
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
- •Age ≥ 18 years
- •Congenital heart disease of all complexities
- •NYHA Class II or III
排除标准
- •Inability to give informed consent
- •Inability to participate in an exercise training program
- •Exercise-induced arrhythmia and/or ischemia
- •Cyanosis at rest
- •Pregnancy
- •Major cardiovascular event and/or procedure within three months previous to inclusion.
- •Participation in interventional clinical trial
结局指标
主要结局
Primary safety endpoint: composite of hospitalizations, deaths during, or within three hours after exercise
时间窗: between 3 hours after exercise for the duration of the 6 months study period
The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise.
Primary efficacy endpoint: change in peak VO2
时间窗: 6 months
change in peak VO2 between baseline and 6-months follow-up CPET
次要结局
- Secondary efficacy endpoint: NTproBNP level(6 months)
- Secondary efficacy endpoint: quality of life(6 months)
- Secondary safety endpoint: composite of all exercise related injuries for which medical attention is sought(6 months study period)
研究者
Berto J Bouma
MD, PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)