TREPROSTINIL in Pulmonary Hypertension: Evidence and Clinical Trends
2026년 7월 26일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (추정된)
300
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
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연구 인구
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.
설명
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)
공부 계획
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디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change From Baseline in 6-Minute Walk Distance at Month 12
기간: Baseline and Month 12
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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.
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Baseline and Month 12
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Number and Percentage of Participants by Change in New York Heart Association Functional Class at Month 12
기간: Baseline and Month 12
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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.
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Baseline and Month 12
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Number and Percentage of Participants With Local Administration-Site Reactions During the First 12 Months
기간: From baseline through Month 12
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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
기간: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
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Local pain associated with parenteral treprostinil application will be assessed on a numerical rating scale from 0 to 10. Higher scores indicate greater pain.
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Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, and Month 12
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Mean Change From Baseline in N-Terminal Pro-B-Type Natriuretic Peptide at Month 12
기간: Baseline and Month 12
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Mean change in N-terminal pro-B-type natriuretic peptide concentration from baseline to Month 12.
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Baseline and Month 12
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Mean Change From Baseline in B-Type Natriuretic Peptide at Month 12
기간: Baseline and Month 12
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Mean change in B-type natriuretic peptide concentration from baseline to Month 12.
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Baseline and Month 12
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Overall survival
기간: From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
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Overall survival is defined as the time from initiation of parenteral treprostinil to death from any cause.
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From initiation of parenteral treprostinil until death from any cause, assessed up to 36 months
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Number and Percentage of Participants by Reason for Early Initiation of Parenteral Treprostinil
기간: Baseline
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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.
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Baseline
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Mean Parenteral Treprostinil Dose at each visit
기간: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Parenteral treprostinil dose will be summarized at each visit.
Dose will be reported in the unit ng/kg/min.
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Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Number and Percentage of Participants by Route of Parenteral Treprostinil Administration
기간: Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Number and percentage of participants receiving parenteral treprostinil by subcutaneous or intravenous administration at each visit.
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Baseline, Week 2, Week 4, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Number and Percentage of Participants Receiving Concomitant Pulmonary Arterial Hypertension Therapy
기간: Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Number and percentage of participants receiving each recorded category of concomitant pulmonary arterial hypertension therapy.
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Baseline, Month 3, Month 6, Month 9, Month 12, Month 18, Month 24, Month 30, and Month 36
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Time to First Composite Clinical Worsening Event
기간: From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
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Time from initiation of parenteral treprostinil to the first occurrence of death from any cause, PAH-related hospitalization, or lung transplantation.
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From initiation of parenteral treprostinil until the first composite clinical worsening event, assessed up to 36 months
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Number and Percentage of Participants With Adverse Events
기간: From baseline through Month 36
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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.
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From baseline through Month 36
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2029년 12월 1일
연구 완료 (추정된)
2031년 12월 1일
연구 등록 날짜
최초 제출
2026년 7월 20일
QC 기준을 충족하는 최초 제출
2026년 7월 26일
처음 게시됨 (실제)
2026년 7월 30일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 30일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 26일
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- TRESPECT
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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