Comprehensive O2 Transfer Analysis From the Lung to Mitochondria of Inhaled Treprostinil in Interstitial Lung Disease Pulmonary Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Cardiac Output Reserve (Qc)
研究概览
简要总结
The purpose of this research study is to find out more about the drug treprostinil via inhaler and the mechanisms of why patients with pulmonary arterial hypertension related to Interstitial Lung disease (PAH-ILD) have limitations during exercise. The investigator is studying treprostinil's effect on patients with PAH-ILD during exercise and its effect on their quality of life after using it for 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with Pulmonary Arterial Hypertension due to Interstitial Lung Disease (ILD-PAH) being considered for inhaled treprostinil
- •Resting right heart catheterization with mean pulmonary artery pressure >20 mmHg and PVR> 3 Wood units
- •Healthy volunteers will have no known lung disease, heart failure, muscular disease or pulmonary hypertension, no bleeding abnormalities, and have the ability to exercise.
排除标准
- •Inability to exercise
- •Females who are pregnant
研究组 & 干预措施
Healthy Volunteers
Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.
干预措施: Right Heart Catheterization (RHC) while exercising (Diagnostic Test)
Healthy Volunteers
Healthy volunteers will undergo RHC while exercising and an optional muscle biopsy.
干预措施: Optional Muscle Biopsy (Diagnostic Test)
PAH-ILD Patients
Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.
干预措施: Treprostinil (Drug)
PAH-ILD Patients
Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.
干预措施: Right Heart Catheterization (RHC) while exercising (Diagnostic Test)
PAH-ILD Patients
Patients diagnosed with PAH-ILD will undergo RHC while exercising, receive inhaled treprostinil, and undergo an optional muscle biopsy.
干预措施: Optional Muscle Biopsy (Diagnostic Test)
结局指标
主要结局
Cardiac Output Reserve (Qc)
时间窗: Baseline, approximately 35 minutes
Cardiac output reserve (Qc) is the difference between the heart's maximum output during exercise and its resting output. This was measured using the direct Fick method (L/min).
次要结局
- Ventilatory Efficiency (VE/VCO2)(Baseline, approximately 35 minutes)
- Resting Pulmonary Vascular Resistance(Baseline; after 30 minutes of rest)
- Exercise Pulmonary Vascular Resistance(Baseline; approximately 35 minutes)
- Resting Pulmonary Artery Pressure(Baseline; after 30 minutes of rest)
- New York Heart Association (NYHA) Functional Class(Baseline, 3-months)
- Exercise Pulmonary Artery Pressure(Baseline; approximately 35 minutes)
- Resting Right Atrial Pressure(Baseline; after 30 minutes of rest)
- Exercise Right Atrial Pressure(Baseline; approximately 35 minutes)