Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension (RESPONS)
2012年10月3日 更新者：Vincent Mainguy、Laval University
Reproducibility and Responsiveness of Exercise Tests in Pulmonary Arterial Hypertension
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.
研究概览
研究类型
介入性
注册 (实际的)
22
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Quebec
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Québec、Quebec、加拿大、G1V 4G5
- Centre de recherche de l'Institut universitaire de cardiologie et de pneumologie de Québec (CRIUCPQ)
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 80年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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Sildenafil citrate is a phosphodiesterase type-5 inhibitor.
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.
其他名称：
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安慰剂比较：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.
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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.
大体时间：3 months
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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.
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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To assess the efficacy of a combination therapy in pulmonary arterial hypertension (PAH).
大体时间：1 month
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Sildenafil will be added to the baseline therapy for one month (20mg tid).
The efficacy of this combined therapy will be assessed by three different exercise tests and by a quality of life questionnaire.
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1 month
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To measure the physiological parameters induced by five different exercise tests in pulmonary arterial hypertension (PAH)
大体时间：2 weeks
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Within one week, PAH patients will performed five different exercise tests.
During each test, a portable telemetric system (Oxycon, Jaegger, Germany) will be used to assess the respiratory cardiovascular adaptations.
Symptoms of leg fatigue and dyspnea will be assessed using the Borg scale.
Quadriceps fatigability will be assessed by volitional and non-volitional (twitch force, TWq) measurements of the quadriceps strength before and immediately after each test (Magstim Co. Ltd., Whitland, Dyfed, Wales, UK).
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2 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Steeve Provencher, MD, M.Sc.、Laval University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年4月1日
初级完成 (实际的)
2011年11月1日
研究完成 (实际的)
2011年11月1日
研究注册日期
首次提交
2011年7月7日
首先提交符合 QC 标准的
2011年7月7日
首次发布 (估计)
2011年7月11日
研究记录更新
最后更新发布 (估计)
2012年10月4日
上次提交的符合 QC 标准的更新
2012年10月3日
最后验证
2012年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.