TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
2026年7月26日 更新者：AOP Orphan Pharmaceuticals AG
Multicenter Registry Evaluating Real-World Therapeutic Patterns and Outcomes in Newly Diagnosed Adult Patients With Pulmonary Arterial Hypertension (PAH) Treated With Parenteral Treprostinil
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.
研究概览
研究类型
观察性的
注册 (估计的)
300
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
The registry will include approximately 100-300 adult patients (≥18 years of age) with confirmed pulmonary arterial hypertension (PAH), classified as Group 1 according to the prevailing ESC/ERS guidelines, who initiated parenteral treprostinil administered subcutaneously or intravenously on or after January 1, 2024.
Written informed consent will be required for prospective data collection and for retrospective medical chart review, as applicable under local regulations.
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients Treated With Parenteral Treprostinil
Adult patients with confirmed pulmonary arterial hypertension who initiated parenteral treprostinil administered by the subcutaneous or intravenous route within 12 months of PAH diagnosis.
Treatment selection, route of administration, dosing, titration, concomitant PAH therapy, and clinical management are determined by the treating physician according to routine clinical practice.
Clinical, treatment, safety, and outcome data are collected retrospectively and/or prospectively as part of this observational registry.
|
Parenteral treprostinil administered by continuous subcutaneous or intravenous infusion as part of routine clinical care.
The decision to initiate treatment, route of administration, starting dose, dose titration, treatment duration, and use of concomitant PAH therapies are determined by the treating physician and are not assigned by the registry.
Data on treatment initiation, doses at approximately 2 and 4 weeks, longitudinal dosing, route of administration, tolerability, local site reactions, pain, treatment changes, and clinical outcomes are collected during registry follow-up.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change From Baseline in 6-Minute Walk Distance at Month 12
大体时间：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.
|
Baseline and Month 12
|
|
Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12
大体时间：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.
|
Baseline and Month 12
|
|
Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months
大体时间：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.
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From baseline through Month 12
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Mean Local Pain Score During the First 12 Months
大体时间：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.
|
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
大体时间：Baseline and Month 12
|
Mean change in N-terminal pro-B-type natriuretic peptide concentration from baseline to Month 12.
|
Baseline and Month 12
|
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Mean Change From Baseline in B-Type Natriuretic Peptide at Month 12
大体时间：Baseline and Month 12
|
Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
|
Baseline and Month 12
|
|
Overall survival
大体时间：From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
|
Overall survival is defined as the time from initiation of parenteral treprostinil to death from any cause.
|
From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
|
|
Number and Percentage of Participants by Reason for Early Initiation of Parenteral Treprostinil
大体时间：Baseline
|
Number and percentage of participants in each documented category of clinical reason for initiating parenteral treprostinil within 12 months of PAH diagnosis, irrespective of baseline risk category.
|
Baseline
|
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Mean Parenteral Treprostinil Dose at each visit
大体时间：Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
Parenteral treprostinil dose will be summarized at each visit.
Dose will be reported in the unit ng/kg/min.
|
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
|
Number and Percentage of Participants by Route of Parenteral Treprostinil Administration
大体时间：Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
Number and percentage of participants receiving parenteral treprostinil by subcutaneous or intravenous administration at each visit.
|
Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
|
Number and Percentage of Participants Receiving Concomitant Pulmonary Arterial Hypertension Therapy
大体时间：Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
Number and percentage of participants receiving each recorded category of concomitant pulmonary arterial hypertension therapy.
|
Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
|
|
Time to First Composite Clinical Worsening Event
大体时间：From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
|
Time from initiation of parenteral treprostinil to the first occurrence of death from any cause, PAH-related hospitalization, or lung transplantation.
|
From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
|
|
Number and Percentage of Participants With Adverse Events
大体时间：From baseline through Month 36
|
Number and percentage of participants experiencing at least one adverse event during registry follow-up.
Adverse events will be summarized by seriousness, severity, outcome, causal relationship to treprostinil, and action taken with treatment.
|
From baseline through Month 36
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2029年12月1日
研究完成 (估计的)
2031年12月1日
研究注册日期
首次提交
2026年7月20日
首先提交符合 QC 标准的
2026年7月26日
首次发布 (实际的)
2026年7月30日
研究记录更新
最后更新发布 (实际的)
2026年7月30日
上次提交的符合 QC 标准的更新
2026年7月26日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- TRESPECT
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研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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