Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605326
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension A Single-Arm Retrospective Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Subcutaneous Treprostinil as a Bridge to Lung Transplantation in Severe Pulmonary Hypertension A Single-Arm Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None