Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension: A Single-Arm Retrospective Study

Guangzhou Institute of Respiratory Disease

Status and phase: Completed; Phase 4

Conditions: Lung Transplantation; Heart Failure; Pulmonary Hypertension; Pulmonary Arterial Hypertension; Chronic Lung Disease-Associated Pulmonary Hypertension

Treatments: Drug: Subcutaneous Treprostinil

Study type: Interventional

Funder types: Other

Identifiers

NCT06605326

2022K-48

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Subcutaneous Treprostinil Group

Experimental group

Description:

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.

Treatment:

Drug: Subcutaneous Treprostinil