Ignite Creation Date:
2024-05-06 @ 2:24 PM
Last Modification Date:
2024-10-26 @ 1:30 PM
Study NCT ID:
NCT04309838
Status:
UNKNOWN
Last Update Posted:
2020-03-16
First Post:
2020-02-20
Brief Title:
Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension
Sponsor:
University Medicine Greifswald
Organization:
University Medicine Greifswald
Study Overview
Official Title:
LENUS Pro Study LPS-II - Observation Study With Implantable Medication Pump for Intravenous REMODULIN Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LPS-II
Brief Summary:
The study is designed as a non-interventional multicenter prospective single-arm study to observe the therapy with REMODULIN Treprostinil applicated by an implantable pump in patients with pulmonary arterial hypertension PAH
Detailed Description:
Patients that suffer from progressing PAH are medicated with intravenous prostanoids since the 80s of the last century Nowadays specific treatment of PAH can be realized by the huge number of substances that are currently available Still the time point of starting an intravenous medication is not defined yet By evaluation of data concerning risk strata of PAH patients this issue may be enlightened properly
Previously collected data concerning risk-adapted therapy in PAH-patient have shown that the mortality is little in the low-risk-status patients only Thus all efforts must be undertaken to define the patients in this functional class For most patients this means a combined therapy of available substances according to well defined procedures Patients whose status remain as intermediate-risk-status after receiving a dual therapy over 3-6 months shall undergo a subsequent triple therapy including Selexipag However this therapy may not lead to an improvement of the risk-status or even worsened In these cases a subcutaneous or intravenous therapy with prostanoids is indicated
Currently there are no data available for those patients treated with at least three months with Selexipag as part of a triple therapy that undergo a subsequent intravenous therapy with Treprostinil if there is no change in their risk-status In the planned study LPS-II patients are specifically selected on being treated in a dual therapy and having a stagnating intermediate-risk status These patients receive an implantation of the medical pump LENUS pro that enables a permanent infusion of Treprostinil
The aim of this study is to examine whether patients can reach an improvement in their intermediate-risk-status after six months of treatment
Previously collected data concerning risk-adapted therapy in PAH-patient have shown that the mortality is little in the low-risk-status patients only Thus all efforts must be undertaken to define the patients in this functional class For most patients this means a combined therapy of available substances according to well defined procedures Patients whose status remain as intermediate-risk-status after receiving a dual therapy over 3-6 months shall undergo a subsequent triple therapy including Selexipag However this therapy may not lead to an improvement of the risk-status or even worsened In these cases a subcutaneous or intravenous therapy with prostanoids is indicated
Currently there are no data available for those patients treated with at least three months with Selexipag as part of a triple therapy that undergo a subsequent intravenous therapy with Treprostinil if there is no change in their risk-status In the planned study LPS-II patients are specifically selected on being treated in a dual therapy and having a stagnating intermediate-risk status These patients receive an implantation of the medical pump LENUS pro that enables a permanent infusion of Treprostinil
The aim of this study is to examine whether patients can reach an improvement in their intermediate-risk-status after six months of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None