NCT05553015

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

January 17, 2024

Status Verified

September 1, 2023

Enrollment Period

4.7 years

First QC Date

September 20, 2022

Last Update Submit

January 16, 2024

Conditions

Pulmonary HypertensionMedication Therapy Management

Keywords

Pulmonary hypertensionTrepostinil sodium

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Incidence of adverse events

    1 year

Study Arms (1)

PH Patients receiving treprostinil sodium treatment

Patients with pulmonary hypertension receiving treprostinil sodium treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with pulmonary hypertension receiving treprostInil sodium treatment.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center of pulmonary vascular disease, Fuwai hospital

Beijing, 100041, China

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Study Officials

  • Zhihong Liu, MD#PhD

    Fuwai Hospital, National Center for Cardiovascular Diseases

    STUDY DIRECTOR

Central Study Contacts

Zhihong Liu, M.D

CONTACT

8601088396590zhihongliufuwai@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2022

First Posted

September 23, 2022

Study Start

December 24, 2020

Primary Completion

August 30, 2025

Study Completion

December 31, 2025

Last Updated

January 17, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)