A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)

Recruiting

• Conditions: Pulmonary Hypertension; Medication Therapy Management

• Registration Number: NCT05553015
• Lead Sponsor: Chinese Pulmonary Vascular Disease Research Group

Brief Summary

A Real-World Registry investigate Treprostinil sodium used in patients with Pulmonary Hypertension (Re-TRIUMPH).

Detailed Description

This study is a multicenter, prospective, single-arm, observational, real-world study conducted in China. Patients who are at least 18 years of age, have been diagnosed with pulmonary hypertension (PH), agree to participate and meet the eligibility requirement will be enrolled in 20 pulmonary vascular centers across the country for the medically reasonable use of intravenous (or subcutaneous) Treprostinil injections. In the event that eligible patients are enrolled in the study, all aspects will be carried out in an observational manner, and no additional methods or procedures will be necessary. The patient and the physician will jointly determine the clinical management of the patient, including the length of treatment. Patients will be followed up for an observation period of at least 1 year. As part of standard clinical practice, patient data will be collected at the first appointment and every three to six months thereafter. After one year of follow-up, data collection will cease.The main purpose is to evaluate the efficacy and adverse reactions of subcutaneous (intravenous) prostacyclin in the treatment of pulmonary hypertension under current clinical practice. The secondary objectives is to understand the drug treatment plan of treprostinil in clinical practice of patients with pulmonary arterial hypertension in China and to understand the efficacy and adverse reactions of treprostinil in the treatment of patients with different types of pulmonary hypertension.

Study Timeline

• Study Start: 2020-12-24
• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2023-09
• Last Update Submitted: 2024-01-16
• Last Update Posted: 2024-01-17
• Primary Completion: 2025-08-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Patients with pulmonary hypertension who consent to receiving Treprostinil injection;
• Patients who must be over the age of 18;
• The informed consent form must be signed.

Exclusion Criteria

• Patients who have received Treprostinil Injection for less than two weeks;
• Patients who have used Treprostinil within the past three months;
• Any situation that the investigator believes could affect the interpretation of the study results or pose a risk to patients using Treprostinil.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1-year transplant event-free survival in patients with pulmonary hypertension	1 year	1-year transplant event-free survival in patients with pulmonary hypertension

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events	1 year	Incidence of adverse events

Trial Locations

Locations (1)

Center of pulmonary vascular disease, Fuwai hospital; 🇨🇳 Beijing, China