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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subcutaneous Treprostinil | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline to 3-6 months after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Change in NT-proBNP Levels | NT-proBNP levels will be measured before and after treatment to assess changes in cardiac function. | Baseline to 3-6 months after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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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.
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|
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| D006333 | Heart Failure |
| D055031 | Primary Graft Dysfunction |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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