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

Sponsor

University Medicine Greifswald (Other)

Overall Status

Unknown status

CT.gov ID

NCT04309838

Collaborator

OMT GmbH & Co. KG (Other)

Enrollment

Locations

Anticipated Duration (Months)

3.8

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension PAH	Combination Product: Treprostinil via implanted pump

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

30 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Outcome Measures

Primary Outcome Measures

Recovery of clinical stability criteria [Baseline and after 6 months intravenous therapy with Treprostinil]
to achieve "low-risk-status"

Secondary Outcome Measures

Quality of Life [Baseline and after 6 months intravenous therapy with Treprostinil]
Assessment of Quality of Life by EQ-5D-5F questionnaire (patient reported)
Restrictions caused by the implant [immediately after implantation until 6 months intravenous therapy with Treprostinil]
Assessment of restrictions that may cause by the implant: mobility, pain, rubor, swelling
Polysomnography [Baseline and after 6 months intravenous therapy with Treprostinil]
Record of hypnogram: duration of sleep, respiratory analysis, quantity and severity of apnea and hypopnea, snoring, oxygen saturation, heart rate, Continuous Positive Airway Pressure

Other Outcome Measures

Adverse Events associated with the implant [at any visit]
Record of all security related adverse events related to implantation of the pump: infections (local, systemic), seroma/hematoma, dysfunction of the pump, other complications associated with the catheter

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosis of pulmonary arterial hypertension (WHO group I) accordingly to international guidelines
intermediate or high risk-profile of PAH after at least three months treatment with vasoactive substances including Selexipag
indication of intravenous therapy with Treprostinil
informed consent given for implantation of the medical pump LENUS pro
informed consent given for participation in the LPS-II study

Exclusion Criteria:

contraindications according to package information leaflet (LENUS pro) and/or summary of product characteristics (Treprostinil)
Patient is diagnosed with PAH with an etiology different from that of the inclusion criteria
chronic kidney insufficiency (estimated GFR < 30)
hepatic insufficiency: CHILD C (known information from patients medical records)
intake of substances with potential for infections: intravenous drug abuse, prednisolone, azathioprine, cyclophosphamide
suffering from diseases with potential for infections: immunodeficiency syndrome, diabetes mellitus, diabetic gangrene
pregnant or breastfeeding women
women of childbearing potential who are not on a reliable and safe form of contraception

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	DRK Kliniken Berlin Westend	Berlin	Germany	14050
2	Universitätsklinikum Gießen	Gießen	Germany	35392
3	Universitätsmedizin Greifswald	Greifswald	Germany	17489
4	Universitätsklinikum Hamburg Eppendorf	Hamburg	Germany	20246
5	Medizinische Hochschule Hannover	Hannover	Germany	30625
6	Universitätsklinikum Heidelberg	Heidelberg	Germany	69126
7	Uniklinik Köln	Köln	Germany	50937
8	Universitätsklinikum Regensburg	Regensburg	Germany	93053