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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05553015
Enrollment
450
Registered
2022-09-23
Start date
2020-12-24
Completion date
2025-12-31
Last updated
2024-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Therapy Management, Pulmonary Hypertension

Keywords

Pulmonary hypertension, Trepostinil sodium

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.

Interventions

None listed

Sponsors

Chinese Pulmonary Vascular Disease Research Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1-year transplant event-free survival in patients with pulmonary hypertension1 year1-year transplant event-free survival in patients with pulmonary hypertension

Secondary

MeasureTime frameDescription
Incidence of adverse events1 yearIncidence of adverse events

Countries

China

Contacts

Primary ContactZhihong Liu, M.D
zhihongliufuwai@163.com8601088396590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026