Registry investigating Treprostinil sodium for pulmonary hypertension

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

This study is trying to see how well Treprostinil sodium works for people with pulmonary hypertension and what side effects it might have over a year of treatment.

Quick facts

• Study type: Observational
• Enrollment: 450 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Chinese Pulmonary Vascular Disease Research Group (Academic / other)
• Locations: 1 site (Beijing)
• Trial ID: NCT05553015 on ClinicalTrials.gov

What this trial studies

This multicenter, prospective, single-arm observational study aims to evaluate the use of Treprostinil sodium in patients diagnosed with pulmonary hypertension across 20 centers in China. Patients aged 18 and older who consent to participate will be enrolled and followed for at least one year, during which their treatment and outcomes will be monitored in a real-world clinical setting. The study focuses on assessing the efficacy and adverse reactions of Treprostinil, as well as understanding the treatment plans for patients with different types of pulmonary hypertension. Data will be collected at regular intervals to ensure comprehensive evaluation.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old diagnosed with pulmonary hypertension who consent to receive Treprostinil injections.

Not a fit: Patients who have recently received Treprostinil injections or those with conditions that may affect study results may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of Treprostinil sodium for patients with pulmonary hypertension.

How similar studies have performed: While this study is observational, similar approaches in evaluating treatments for pulmonary hypertension have shown promise in other settings.

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.

Where this trial is running

Beijing

• Center of pulmonary vascular disease, Fuwai hospital — Beijing, China (Recruiting)

Study contacts

• Study coordinator: Zhihong Liu, M.D

Conditions Pulmonary Hypertension; Medication Therapy Management; Pulmonary hypertension; Trepostinil sodium