A Safety and Clinical Efficacy Study Measuring Echocardiographic Composite Comparing Ambrisentan (Letairis®) After a Switch From Bosentan (Tracleer®) or Macintentan (Opsumit®) in Treatment of Pulmonary Arterial Hypertension (PAH)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in Stroke Volume
研究概览
简要总结
The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
详细描述
The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Diagnosis of a Connective Tissue Disease (CTD)
- •Age range: 18-80 years old
- •Previous Right Heart Catheterization (RHC) demonstrating PAH
- •Forced vital capacity (FVC) greater than 50%
- •Carbon Monoxide Diffusing Capacity (DLCO) greater than 50%
- •World Health Organization (WHO) functional class II or III
- •Able to perform a 6 minute walk test (6MWT)
- •Stable dose of antihypertensive medications
- •Non-pregnant females
- •Have to be currently on stable dose of bosentan for at least 3 months
- •Adequate acoustic images to allow for transthoracic echocardiography to be performed
排除标准
- •Exercise limitation related to a non-cardiopulmonary reason (e.g. arthritis)
- •Severe systemic hypertension greater than 170/95
- •Patients with a prior history of cardiovascular disease
- •WHO functional class IV status
- •Patients with severe other organ disease felt by investigators to impact on survival during the course of the study.
- •FVC less than 50% of predicted
- •DLCO less than 50% of predicted
研究组 & 干预措施
Switch to Letairis from Bosentan
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
干预措施: Ambrisentan (Drug)
Switch to Letairis from Macitentan
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
干预措施: Ambrisentan (Drug)
结局指标
主要结局
Change in Stroke Volume
时间窗: Baseline and 24 Weeks
Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat.
次要结局
- Change in EmPHasis-10 Score(Baseline and 24 Weeks)
- Disease Status as Measured by Change in Biomarker(Baseline and 12 Weeks)