Early Intervention With Inhaled Treprostinil Among Patients With Exercise-Induced Pulmonary Hypertension: A Prospective Open-Label Matched Control Pilot Trial.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Exercise Pulmonary Vascular Resistance (PVR)
研究概览
简要总结
This prospective open-label matched-control pilot study evaluates whether inhaled treprostinil improves exercise pulmonary vascular resistance and functional outcomes in adults with interstitial lung disease or connective tissue disease and exercise-induced pulmonary hypertension. Participants will receive inhaled treprostinil plus standard care or standard care alone and will be followed for 6 months, with an optional extension to 12 months.
详细描述
1.1 Purpose/Specific Aims This pilot study aims to determine whether early treatment of exercise-induced pulmonary hypertension with inhaled Treprostinil can improve pulmonary vascular hemodynamics, preserve cardiopulmonary reserve, and delay progression to overt resting pulmonary hypertension in patients with interstitial lung disease (ILD) or connective tissue disease (CTD).
A. Objectives
Primary Objective:
• To evaluate the effect of inhaled treprostinil on exercise pulmonary vascular resistance (PVR) at 6 months in patients with PH-ILD or PH-CTD exercise-induced pulmonary hypertension.
Secondary Objectives:
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
- 否
入选标准
- •Age ≥18 years
- •ILD diagnosis or CTD diagnosis
- •WHO Functional Class II-III
- •Resting RHC:
- •mPAP ≤20 mmHg
- •PVR ≤2 WU
- •PAWP ≤15 mmHg
- •Exercise-induced pulmonary hypertension on iCPET
- •Able to provide informed consent
排除标准
- •Resting pulmonary hypertension
- •Significant left heart disease
- •Acute PE within 6 months
- •Current PAH-targeted therapy
- •Pregnancy or breastfeeding
- •Severe renal or hepatic impairment
- •Inability to perform exercise testing
- •Contraindication to RHC
- •Treprostinil hypersensitivity
研究组 & 干预措施
Standard of Care
Participants receive standard disease-specific care without inhaled treprostinil
干预措施: Standard of Care (Other)
Inhaled Treprostinil Plus Standard of Care
Participants receive inhaled treprostinil (Tyvaso) in addition to standard disease-specific care.
干预措施: Treprostinil (Drug)
结局指标
主要结局
Change in Exercise Pulmonary Vascular Resistance (PVR)
时间窗: Baseline to Month 6
Change in exercise pulmonary vascular resistance (PVR) from baseline to Month 6, measured during exercise right heart catheterization with invasive cardiopulmonary exercise testing (iCPET). The primary analysis will compare the change in exercise PVR between the inhaled treprostinil and standard-of-care groups
次要结局
- Incidence of Adverse Events and Treatment Discontinuations(Through Month 6)
- Progression to Resting Pulmonary Hypertension(Month 12)
- Change in Exercise Pulmonary Vascular Resistance (PVR) at Month 12(Month 12)
- Change in Right Ventricular Stroke Work Index (RVSWI) at Month 6(Baseline to Month 6)
- Change in Pulmonary Arterial Compliance at Month 6(Baseline to Month 6)
- Change in 6-Minute Walk Distance at Month 6(Baseline to Month 6)
- Change in Dyspnea Severity (Borg Scale) at Month 6(Baseline to Month 6)
- Change in 6-Minute Walk Distance at Month 12(Month 12)
- Change in Mean Pulmonary Artery Pressure/Cardiac Output (mPAP/CO) Slope at Month 6(Baseline to Month 6)
- Change in Dyspnea Severity (Borg Category Ratio [CR10] Dyspnea Scale) at Month 12(Month 12)