Ambrisentan for the Improvement in Right Ventricular Strain in Scleroderma Associated Pulmonary Arterial Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Improvement in right ventricular (RV) myocardio strain > 2%
研究概览
简要总结
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.
详细描述
This research study is looking at the use of the drug ambrisentan and if it can improve right ventricle function in people with systemic sclerosis-associated pre-pulmonary arterial hypertension. It is also looking at using right ventricle function changes as a marker of disease severity.
Pre-pulmonary arterial hypertension is a borderline elevation in blood pressure in the lungs. Pre-pulmonary arterial hypertension is not currently treated with the drug therapies that are used for pulmonary arterial hypertension. It represents a group of patients that are at risk for developing pulmonary arterial hypertension.
The administration of ambrisentan is the experimental part of this study. Ambrisentan has not been approved by the FDA for use of improving right ventricle function in people with pre-pulmonary arterial hypertension. You will still receive your normal clinical care.
The purpose of this study is to learn more about ambrisentan and its role in treating systemic sclerosis-associated pre-pulmonary arterial hypertension. Ambrisentan is already approved for use in people with systemic sclerosis-associated pulmonary arterial hypertension, but this study wants to research its role in people with pre-pulmonary arterial hypertension.
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
- Double (Participant, Investigator)
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
- •Age >18 years, < 80 years
- •Systemic sclerosis with any of the following features:
- •Duration of Raynaud's phenomena >8 years
- •Anticentromere antibody positivity
- •isolated nucleolar-pattern ANA positivity
- •Extensive telangiectasias
- •DLCO < 60% in the absence of extensive ILD
- •FVC%/DLCO% >1.6
- •Unexplained dyspnea
- •Right heart catheterization-proven pre PAH (mean PAP 20-25 mmHg and pulmonary capillary wedge pressure <15 mmHg)
- •Systolic blood pressure >100 mmHg
- •Reliable contraception for women of childbearing age
- •Informed consent
排除标准
- •< 18 years or > 80 years
- •Left ventricular ejection fraction < 55%
- •Systolic or diastolic left ventricular congestive heart failure
- •Liver disease (abnormal AST/ALT, chronic hepatitis, or cirrhosis)
- •Extensive ILD or FVC< 60%
- •Breast-feeding women
- •Cyclosporine use
研究组 & 干预措施
Ambrisentan
Subjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan.
干预措施: Ambrisentan (Drug)
Placebo
Subjects will be randomly assigned in a 1:1 ration according to the computer generated random numbers to receive either placebo (sugar pill) or ambrisentan.
干预措施: Ambrisentan (Drug)
结局指标
主要结局
Improvement in right ventricular (RV) myocardio strain > 2%
时间窗: 1, 3 and 6 months
Assess for tolerance, gas exchange, and therapeutic benefit, resting oximetry, six minute walk with oximetry, pulmonary function testing with diffusion capacity (DLCO), and functional class will be assessed prior to ambrisentan initiation, and 1,3, and 6 months.
次要结局
未报告次要终点