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
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).
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.
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