NCT01397110招募中不适用
Influence of Respiratory and Exercise Therapy on Oxygen Uptake, Quality of Life in Patients With Severe Associated Pulmonary Arterial Hypertension (APAH) as Part of a Congenital Heart Defect With / Without Eisenmenger's Syndrome
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Changes in the maximum 6-minute walk distance (6MGT)
研究概览
简要总结
The purpose of this study is to investigate the influence of physical training on exercise capacity, quality of life, functional class, oxygen consumption and right ventricular function in patients with severe associated pulmonary arterial hypertension (APAH) as part of a congenital heart defect with / without Eisenmenger's Syndrome
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •signed consent form
- •men and women> 18 years <80 years
- •APAH with congenital heart defects with / without Eisenmenger syndrome (WHO functional class II-IV), invasively diagnosed by right heart and left heart catheterization: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg, with targeted PAH medication for at least two months stable before study inclusion (exception: compensated WHO class II without vasodilating drug therapy)
排除标准
- •Pregnancy or lactation
- •Change in medication during the last 2 months
- •severe walking disturbance
- •uncertain diagnoses
- •No previous invasively confirmation of PH
- •acute diseases, infections, fever
- •Serious lung disease with FEV1 <50% or TLC <70% of target
- •Further exclusion criteria are the following diseases: active myocarditis, unstable angina pectoris, exercise-induced ventricular arrhythmias, recurrent syncope within 4 weeks before study entry
结局指标
主要结局
Changes in the maximum 6-minute walk distance (6MGT)
时间窗: up to 15 weeks
Changes in quality of life
时间窗: up to 15 weeks
次要结局
- Changes in hemodynamics(up to 15 weeks)
研究者
Prof. Dr. med. Ekkehard Gruenig
Prof. Dr. med. Ekkehard Grünig
Heidelberg University
研究点 (2)
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