Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Mean Change From Baseline in 6-Minute Walk Distance at Month 12
研究概览
简要总结
TRESPECT is an international, multicenter, observational registry designed to describe the real-world use, effectiveness, and tolerability of parenteral treprostinil in adults with newly diagnosed pulmonary arterial hypertension (PAH). The registry will include patients who initiated subcutaneous or intravenous treprostinil within 12 months of PAH diagnosis.
Both retrospective and prospective data will be collected from routine clinical care. Data will include patient characteristics, PAH treatment patterns, treprostinil dosing and route of administration, functional status, exercise capacity, biomarkers, echocardiographic and hemodynamic parameters, clinical events, and adverse events. Participants will be followed for at least 36 months or until a registry termination criterion is met. The registry is expected to enroll approximately 100 to 300 patients across specialized PAH centers in several European countries.
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
- •Adult patient (≥18 years)
- •Confirmed diagnosis of PAH (i.e. Group 1 as defined by ESC/ERS guidelines)
- •Initiated on parenteral Treprostinil (SC or IV) anytime from 1/1/2024
- •Informed consent (prospective data or retrospective chart review, per local regulations)
排除标准
- •Participation in any interventional trials affecting PAH (including patients from TripleTRE study)
- •Non-PAH forms of pulmonary hypertension (e.g., ESC-ERS Group 2-5)
结局指标
主要结局
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
时间窗: Baseline and Month 12
Mean change in 6-minute walk distance from baseline to Month 12. The 6-minute walk distance is measured in meters. A positive change indicates improvement in exercise capacity.
Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12
时间窗: Baseline and Month 12
Number and percentage of participants whose New York Heart Association Functional Class improved, remained unchanged, or worsened from baseline to Month 12. Functional Class ranges from Class I to Class IV, with a higher class indicating greater functional limitation.
Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months
时间窗: From baseline through Month 12
Number and percentage of participants experiencing at least one local administration-site reaction associated with subcutaneous or intravenous treprostinil application during the first 12 months after treatment initiation.
Mean Local Pain Score During the First 12 Months
时间窗: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
Local pain associated with parenteral treprostinil application will be assessed on a numerical rating scale from 0 to 10. Higher scores indicate greater pain.
次要结局
未报告次要终点