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

NCT ID: NCT05553015

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-24

Study Completion Date

2025-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pulmonary Hypertension Medication Therapy Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PH Patients receiving treprostinil sodium treatment

Patients with pulmonary hypertension receiving treprostinil sodium treatment

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese Pulmonary Vascular Disease Research Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhihong Liu, MD#PhD

Role: STUDY_DIRECTOR

Fuwai Hospital, National Center for Cardiovascular Diseases

Locations

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Center of pulmonary vascular disease, Fuwai hospital

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhihong Liu, M.D

Role: CONTACT

8601088396590

Facility Contacts

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Zhihong Liu, MD,PhD

Role: primary

+861088396590

Other Identifiers

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TReprostInil

Identifier Type: -

Identifier Source: org_study_id

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