Pulmonary HypertensionPhase 4NCT06605326
Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study
A Phase 4 study testing Subcutaneous Treprostinil in people with Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Guangzhou Institute of Respiratory Disease.
Trial summary
This single-arm, retrospective study aims to evaluate the safety and efficacy of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Chronic Lung Disease-Associated Pulmonary Hypertension
- What is being tested?
- Subcutaneous Treprostinil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Sep 2024
- Phase
- Phase 4
- 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
Who may be able to join
- Patients diagnosed with severe pulmonary hypertension (PAH or CLD-PH) requiring lung transplantation
- Age 18 years or older
- Able to provide informed consent
Who cannot join
- Patients with PH caused by left heart disease
- Patients unable to undergo lung transplantation due to medical conditions
- Patients with a history of severe drug allergies
About this study
This single-arm, retrospective study aims to evaluate the safety and efficacy of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH). A total of 46 patients with either pulmonary arterial hypertension (PAH) or chronic lung disease-associated PH (CLD-PH) were included, all of whom were referred for lung transplantation between January 1, 2015, and September 1, 2024. The study examines changes in clinical, functional, and hemodynamic parameters following 3-6 months of treprostinil therapy.
Read the detailed description
This study evaluates the use of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH), including both pulmonary arterial hypertension (PAH) and chronic lung disease-associated PH (CLD-PH). This retrospective, single-center study included 46 patients treated between January 1, 2015, and September 1, 2024. All patients experienced significant clinical and hemodynamic impairment at the time of treprostinil initiation. The primary aim was to assess improvements in NYHA functional class and 6-minute walk distance (6-MWD) following 3-6 months of therapy. Secondary outcomes included NT-proBNP levels, echocardiographic parameters, and post-transplantation survival rates. The study also analyzed the incidence of primary graft dysfunction (PGD) and the continued use of treprostinil post-transplantation.
- Conditions
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Chronic Lung Disease-Associated Pulmonary Hypertension, Lung Transplantation, Heart Failure
- Being tested
- Subcutaneous Treprostinil
- Keywords
- Subcutaneous Treprostinil, NYHA Functional Class, 6-Minute Walk Distance, Primary Graft Dysfunction (PGD), Retrospective Study, Single-Arm Study
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Heart Failure, Primary Graft Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subcutaneous TreprostinilDrug
Patients in this group received subcutaneous treprostinil, starting at a dose of 1.25 to 4 ng/kg/min and gradually titrated according to patient response. The target dose was over 20 ng/kg/min after 3 months of treatment. All patients were referred for lung transplantation during or after treprostinil treatment.
| Study group | Role | What they receive |
|---|---|---|
| Subcutaneous Treprostinil Group | Experimental | Patients in this group received subcutaneous treprostinil, starting at a dose of 1.25 to 4 ng/kg/min and gradually titrated according to patient response. The target dose was over 20 ng/kg/min after 3 months of treatment. All patients were referred for lung transplantation during or after treprostinil treatment. Receives: Drug: Subcutaneous Treprostinil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NYHA Functional Class
The change in NYHA functional class will be assessed after 3-6 months of treatment with subcutaneous treprostinil. Improvement will be defined as a reduction in class (e.g., from class IV to class III or II).
Measured: Baseline to 3-6 months after treatment initiation
Improvement in 6-Minute Walk Distance (6-MWD)
The 6-minute walk distance (6-MWD) will be measured at baseline and after 3-6 months of subcutaneous treprostinil treatment to evaluate the improvement in exercise capacity.
Measured: Baseline to 3-6 months after treatment initiation
Secondary outcomes (1)
Change in NT-proBNP Levels
NT-proBNP levels will be measured before and after treatment to assess changes in cardiac function.
Measured: Baseline to 3-6 months after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 Jan 2015
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-arm, retrospective study in which all enrolled patients received subcutaneous treprostinil as a bridge therapy for lung transplantation. The study evaluates the efficacy and safety of the treatment in patients with severe pulmonary hypertension, including both PAH and CLD-PH. No randomization or control group is included in the study.
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhibin Xu, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605326
- Sponsor's protocol ID
- 2022K-48
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) from this study. Due to privacy concerns and the sensitive nature of the health data collected, the research team has decided not to make individual-level data available to external researchers. All data will remain confidential and will be used solely for the purposes of this study, in compliance with institutional and ethical guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study
- ClinicalTrials.gov ID
- NCT06605326
- Acronym / sponsor ID
- 2022K-48
- Conditions
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, Chronic Lung Disease-Associated Pulmonary Hypertension, Lung Transplantation, Heart Failure
- Keywords
- Subcutaneous Treprostinil, NYHA Functional Class, 6-Minute Walk Distance, Primary Graft Dysfunction (PGD), Retrospective Study, Single-Arm Study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 20 Sep 2024 (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.
This single-arm, retrospective study aims to evaluate the safety and efficacy of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH). A total of 46 patients with either pulmonary arterial hypertension (PAH) or chronic lung disease-associated PH (CLD-PH) were included, all of whom were referred for lung transplantation between January 1, 2015, and September 1, 2024. The study examines changes in clinical, functional, and hemodynamic parameters following 3-6 months of treprostinil therapy.
Detailed description
This study evaluates the use of subcutaneous treprostinil as a bridge therapy for lung transplantation in patients with severe pulmonary hypertension (PH), including both pulmonary arterial hypertension (PAH) and chronic lung disease-associated PH (CLD-PH). This retrospective, single-center study included 46 patients treated between January 1, 2015, and September 1, 2024. All patients experienced significant clinical and hemodynamic impairment at the time of treprostinil initiation. The primary aim was to assess improvements in NYHA functional class and 6-minute walk distance (6-MWD) following 3-6 months of therapy. Secondary outcomes included NT-proBNP levels, echocardiographic parameters, and post-transplantation survival rates. The study also analyzed the incidence of primary graft dysfunction (PGD) and the continued use of treprostinil post-transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-arm, retrospective study in which all enrolled patients received subcutaneous treprostinil as a bridge therapy for lung transplantation. The study evaluates the efficacy and safety of the treatment in patients with severe pulmonary hypertension, including both PAH and CLD-PH. No randomization or control group is included in the study.
| Arm | Type | Receives |
|---|---|---|
| Subcutaneous Treprostinil Group | Experimental | Drug: Subcutaneous TreprostinilPatients in this group received subcutaneous treprostinil, starting at a dose of 1.25 to 4 ng/kg/min and gradually titrated according to patient response. The target dose was over 20 ng/kg/min after 3 months of treatment. All patients were referred for lung transplantation during or after treprostinil treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with severe pulmonary hypertension (PAH or CLD-PH) requiring lung transplantation
- Age 18 years or older
- Able to provide informed consent
Key exclusion criteria (3 listed)
- Patients with PH caused by left heart disease
- Patients unable to undergo lung transplantation due to medical conditions
- Patients with a history of severe drug allergies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subcutaneous TreprostinilPatients in this group received subcutaneous treprostinil, starting at a dose of 1.25 to 4 ng/kg/min and gradually titrated according to patient response. The target dose was over 20 ng/kg/min after 3 months of treatment. All patients were referred for lung transplantation during or after treprostinil treatment. | Drug | Subcutaneous Treprostinil Group |
Primary outcome
Change in NYHA Functional Class
Time frame: Baseline to 3-6 months after treatment initiation
The change in NYHA functional class will be assessed after 3-6 months of treatment with subcutaneous treprostinil. Improvement will be defined as a reduction in class (e.g., from class IV to class III or II).
Improvement in 6-Minute Walk Distance (6-MWD)
Time frame: Baseline to 3-6 months after treatment initiation
The 6-minute walk distance (6-MWD) will be measured at baseline and after 3-6 months of subcutaneous treprostinil treatment to evaluate the improvement in exercise capacity.
1 secondary outcome
Change in NT-proBNP Levels
Time frame: Baseline to 3-6 months after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) from this study. Due to privacy concerns and the sensitive nature of the health data collected, the research team has decided not to make individual-level data available to external researchers. All data will remain confidential and will be used solely for the purposes of this study, in compliance with institutional and ethical guidelines.
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Subcutaneous Treprostinil in people with Pulmonary Hypertension and Pulmonary Arterial Hypertension, run by Guangzhou Institute of Respiratory Disease.
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: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in NYHA Functional Class (time frame: Baseline to 3-6 months after treatment initiation). The study lists 2 primary outcomes in all. 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 23 Sep 2024.