Reproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in PAH.
研究概览
简要总结
Pulmonary arterial hypertension (PAH) is characterized by the progressive increase in pulmonary vascular resistance leading to shortness of breath and exercise intolerance. Exercise capacity has been used as the primary endpoint in most recent randomized controlled trials evaluating PAH-specific therapies as it correlates with functional class and survival in PAH. Exercise test is commonly assessed by the six-minute walk test (6MWT). However, there is commonly some discrepancy between significant clinical improvement and minor changes (generally <10% from baseline) in 6WMT following therapy. Because important clinical decisions are based on patients' functional capacity, a reproducible and sensitive exercise test is needed in PAH. The aim of this study was to compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •WHO functional class II or III
- •Idiopathic PAH, familial PAH, or associated PAH due to connective tissue disease patients
- •Mean pulmonary artery pressure ≥25 mmHg at rest
- •Pulmonary capillary wedge pressure ≤15 mmHg
排除标准
- •Prior use of phosphodiesterase type-5 inhibitors
- •Unstable clinical condition over the last 4 months
- •Recent syncope
- •WHO functional class IV
- •Left ventricular ejection fraction <40%
- •Restrictive or obstructive lung disease
- •Intrinsic musculoskeletal abnormality precluding exercise testing
- •Patients with a pacemaker
- •Treatment with systemic corticosteroids
研究组 & 干预措施
Sildenalfil
Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
干预措施: Sildenafil (Drug)
Sugar Pill
Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
干预措施: Sugar Pill (Drug)
结局指标
主要结局
To compare the reproducibility and the responsiveness of the 6MWT, the endurance shuttle walk test (ESWT) and the cycle endurance test (CET) following pharmacological therapy in PAH.
时间窗: 3 months
After completing the 6MWT, the ESWT and the CET in a randomized order, patients will then be randomized to sildenafil (20mg tid) or placebo in a double-blind manner for 28 days. The three exercise tests will then be repeated. After a four-week of wash-out period, patients will repeat the three exercise test and then be crossed over to the alternate therapy for the next 28 days. The same experiments will be repeated after this period. The reproducibility of each exercise test will be assessed following placebo. The responsiveness of each exercise test will be assessed following sildenafil.
次要结局
- To assess the efficacy of a combination therapy in pulmonary arterial hypertension (PAH).(1 month)
- To measure the physiological parameters induced by five different exercise tests in pulmonary arterial hypertension (PAH)(2 weeks)