NCT04309838

Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University Medicine Greifswald · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Pulmonary Arterial Hypertension
• PAH

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Treprostinil via implanted pump	Patients, diagnosed with PAH classified in stagnating intermediate-risk status after triple therapy including Selexipag for at least three months will receive the implantation of LENUS pro that enables permanent infusion of Treprostinil.

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-03-01
• Completion: 2021-12-01
• First posted: 2020-03-16
• Last updated: 2020-03-16

Locations

8 sites across 1 country: Germany