Clinical trial NCT06605326: Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study
Official title: Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2024-09-20
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in NYHA Functional Class
timeFrame: Baseline to 3-6 months after treatment initiation
measure: Improvement in 6-Minute Walk Distance (6-MWD)
timeFrame: Baseline to 3-6 months after treatment initiation
Secondary outcomes:
measure: Change in NT-proBNP Levels
timeFrame: Baseline to 3-6 months after treatment initiation
Other outcomes:
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