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Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension — LPS-II  

Pulmonary Arterial Hypertension Clinical Trial

Official title:
LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension

Clinical Trial 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).

Clinical Trial Description

Patients that suffer from progressing PAH are medicated with intravenous prostanoids since the 80's 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04309838
Study type Observational
Source University Medicine Greifswald
Contact Ralf Ewert, Prof. MD
Phone +49 3834 86
Email ralf.ewert@med.uni-greifswald.de
Status Not yet recruiting
Phase
Start date March 2020
Completion date December 2021
View Details
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