NCT02579954已完成不适用
Cardiac Function and Exercise Capacity in Pulmonary Arterial Hypertension
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 18
- 主要终点
- Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
研究概览
简要总结
Pulmonary Arterial Hypertension is characterized by a progressive increase in pulmonary vascular resistance inducing shortness of breath and exercise intolerance. We aim to correlate cardiac function (evaluated at rest by right heart catheterism and RMN) to exercise capacity (evaluated by endurance time at 75% of maximal workout), in prevalent patients with pulmonary arterial hypertension, and their evolution at three and twelve months.
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 (Participant)
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
- •Adult patients
- •Patients with Pulmonary Arterial Hypertension (idiopathic, heritable or due to anorexigens),
- •Prevalent cases of pulmonary artery hypertension (≥ 6 months) confirmed by right heart catheterism,
- •Stable for at least 3 months,
- •Written consent.
排除标准
- •Patients unable to proceed with six-minute walk test or CPET, or with contra-indication to exercise evaluation (syncope, low cardiac index, etc).
- •Exercise induced abnormality (evaluated during the initial CPET) precluding to further evaluation.
结局指标
主要结局
Endurance time at 75% of the maximal workout (determinated during a cardiopulmonary exercise testing - CPET),
时间窗: 12 months after the inclusion
次要结局
- Functional class (NYHA classification)(at 3 and 12 months)
- 6 minutes walking distance (m)(at 3 and 12 months)
- Right ventricular ejection fraction evaluated by RMN(at 3 and 12 months)
- Functional exercise capacity (oxygen consumption measurement during test)(at 3 and 12 months)
- Time to clinical worsening (months)(at 3 and 12 months)
- Quality of life (SF-36 scale)(at 3 and 12 months)
- Pulmonary haemodynamics : measurements at right heart catheterism(at 3 and 12 months)
研究者
研究点 (18)
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