Effects of Pulmonary Hypertension Therapy in Atypical Pulmonary Arterial Hypertension: An Exercise Hemodynamic Study (TAPH Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Evaluate the therapeutic response of chronic pulmonary vasodilator therapy
研究概览
简要总结
The purpose of this study is to characterize the clinical and hemodynamic response of Pulmonary Arterial Hypertension (PAH) therapy in patients with atypical PAH and risk factors for left heart disease.
详细描述
This is an observational prospective study to better understand the clinical impact of Pulmonary Arterial Hypertension (PAH) specific therapy in patients with atypical PAH among those with risk factors for left heart disease
The study involves detailed baseline clinical evaluation prior to initiation of PAH therapy, followed by repeat clinical assessment after 6 months of medical therapy
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age ≥ 18 years
- •Pulmonary hypertension with mean PA pressure >20 mmHg and a planned initiation of pulmonary arterial hypertension therapy
- •No active treatment for precapillary pulmonary hypertension
- •Ambulatory (not wheelchair/scooter dependent)
- •Presence of any risk factor for left heart disease will qualify for inclusion (either atrial fibrillation, body mass index>30 kg/m2, arterial hypertension, diabetes, coronary artery disease or age>60 years)
排除标准
- •Significant chronic obstructive pulmonary disease that is a primary contributor to symptoms in the opinion of the investigator
- •Ischemia thought to contribute to dyspnea in the opinion of the investigator
- •Obstructive hypertrophic cardiomyopathy
- •Known infiltrative cardiomyopathy (amyloid)
- •Constrictive pericarditis or tamponade
- •Active myocarditis
- •Complex congenital heart disease
- •More than mild aortic or mitral stenosis
- •Intrinsic (prolapse, rheumatic) valve disease with more than moderate mitral, tricuspid or aortic regurgitation
- •Acute or chronic severe liver disease as evidenced by any of the following: encephalopathy, variceal bleeding, INR > 1.7 in the absence of anticoagulation treatment
- •Terminal illness (other than HF) with expected survival of less than 1 year
- •Enrollment or planned enrollment in another therapeutic clinical trial in next 3 months.
- •Inability to comply with planned study procedures
- •Pregnancy or breastfeeding mothers
结局指标
主要结局
Evaluate the therapeutic response of chronic pulmonary vasodilator therapy
时间窗: 6 Month Catheterization
Favorable pulmonary vasodilatory effect will be associated a change of \> 10% reduction in pulmonary artery-pressure flow slope from baseline to 6 month catheterization
Describe prevalence of occult left heart disease during exercise in atypical pulmonary hypertension, as defined by pulmonary arterial wedge pressure during exercise cardiac catheterization.
时间窗: Baseline Catheterization
Pulmonary arterial wedge pressure \>25 mmHg during exercise cardiac catheterization will indicate occult left heart disease.
次要结局
未报告次要终点