Chronic Lung Disease-Associated Pulmonary Hypertension, Heart Failure, Lung Transplantation, Pulmonary Arterial Hypertension, Pulmonary Hypertension
Conditions
Keywords
Subcutaneous Treprostinil, NYHA Functional Class, 6-Minute Walk Distance, Primary Graft Dysfunction (PGD), Retrospective Study, Single-Arm Study
Brief 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). 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.
Interventions
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.
Sponsors
Guangzhou Institute of Respiratory Disease
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients diagnosed with severe pulmonary hypertension (PAH or CLD-PH) requiring lung transplantation * Age 18 years or older * Able to provide informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in NYHA Functional Class | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in NT-proBNP Levels | Baseline to 3-6 months after treatment initiation | NT-proBNP levels will be measured before and after treatment to assess changes in cardiac function. |
Outcome results
None listed