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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553015
• Other study ID #: TReprostInil
• Status: Recruiting
• Start date: December 24, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Chinese Pulmonary Vascular Disease Research Group
• Contact: Zhihong Liu, M.D
• Phone: 8601088396590
• Email: zhihongliufuwai[@]163.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Medication Therapy Management
• Pulmonary Hypertension

Locations

Country	Name	City	State
China	Center of pulmonary vascular disease, Fuwai hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Pulmonary Vascular Disease Research Group

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year transplant event-free survival in patients with pulmonary hypertension	1-year transplant event-free survival in patients with pulmonary hypertension	1 year
Secondary	Incidence of adverse events	Incidence of adverse events	1 year