Pulmonary HypertensionNCT05553015
A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)
An observational study of Pulmonary Hypertension and Medication Therapy Management, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
Trial summary
A Real-World Registry investigate Treprostinil sodium used in patients with Pulmonary Hypertension (Re-TRIUMPH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Medication Therapy Management
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 24 Dec 2020to 31 Dec 2025
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pulmonary hypertension receiving treprostInil sodium treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Center of pulmonary vascular disease, Fuwai hospital
Beijing, 100041
Zhihong Liu, MD,PhD, +861088396590, zhihongliufuwai@163.com
Zhihong Liu, MD,PhD
About this study
A Real-World Registry investigate Treprostinil sodium used in patients with Pulmonary Hypertension (Re-TRIUMPH).
Read the 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.
- Keywords
- Pulmonary hypertension, Trepostinil sodium
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PH Patients receiving treprostinil sodium treatment | Patients with pulmonary hypertension receiving treprostinil sodium treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year transplant event-free survival in patients with pulmonary hypertension
1-year transplant event-free survival in patients with pulmonary hypertension
Measured: 1 year
Secondary outcomes (1)
Incidence of adverse events
Incidence of adverse events
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start24 Dec 2020
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhihong Liu, MD#PhD, Study director, Fuwai Hospital, National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05553015
- Sponsor's protocol ID
- TReprostInil
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2022
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-World Registry Investigating TReprostInil sodiUM in Pulmonary Hypertension (Re-TRIUMPH)
- ClinicalTrials.gov ID
- NCT05553015
- Acronym / sponsor ID
- TReprostInil
- Keywords
- Pulmonary hypertension, Trepostinil sodium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Chinese Pulmonary Vascular Disease Research GroupUniversity, hospital or other
- Study start
- 24 Dec 2020 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PH Patients receiving treprostinil sodium treatment | – | –Patients with pulmonary hypertension receiving treprostinil sodium treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pulmonary hypertension receiving treprostInil sodium treatment.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
1-year transplant event-free survival in patients with pulmonary hypertension
Time frame: 1 year
1-year transplant event-free survival in patients with pulmonary hypertension
1 secondary outcome
Incidence of adverse events
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
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A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihong Liu, MD#PhD study director
Fuwai Hospital, National Center for Cardiovascular Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Medication Therapy Management, run by Chinese Pulmonary Vascular Disease Research Group at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhihong Liu, M.D (8601088396590, zhihongliufuwai@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year transplant event-free survival in patients with pulmonary hypertension (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.