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

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

Study Overview

• Status: Recruiting
• Conditions: Pulmonary Hypertension; Medication Therapy Management

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 Type: Observational
• Enrollment (Estimated): 450

Contacts and Locations

• Study Contact: Name: Zhihong Liu, M.D; Phone Number: 8601088396590; Email: zhihongliufuwai@163.com

Study Locations

• China
  • Beijing, China, 100041
    • Recruiting
    • Center of pulmonary vascular disease, Fuwai hospital
    • Principal Investigator: Zhihong Liu, MD,PhD
    • Contact: Zhihong Liu, MD,PhD; Phone Number: +861088396590; Email: zhihongliufuwai@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pulmonary hypertension receiving treprostInil sodium treatment.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
PH Patients receiving treprostinil sodium treatment; Patients with pulmonary hypertension receiving treprostinil sodium treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	Incidence of adverse events	1 year

Collaborators and Investigators

• Sponsor: Chinese Pulmonary Vascular Disease Research Group
• Investigators: Study Director: Zhihong Liu, MD#PhD, Fuwai Hospital, National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): December 24, 2020
• Primary Completion (Estimated): August 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pulmonary hypertension; Trepostinil sodium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension; Hypertension, Pulmonary
• Other Study ID Numbers: TReprostInil

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No