Clinical trial NCT05553015: A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)
Official title: A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Hypertension
Medication Therapy Management
Keywords: Pulmonary hypertension
Trepostinil sodium
Lead sponsor: Chinese Pulmonary Vascular Disease Research Group
Sponsor class: OTHER
First posted: 2022-09-23
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pulmonary hypertension receiving treprostInil sodium treatment.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 1-year transplant event-free survival in patients with pulmonary hypertension
timeFrame: 1 year
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center of pulmonary vascular disease, Fuwai hospital
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Diseases
name: Zhihong Liu, MD#PhD
role: STUDY_DIRECTOR
References: