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

NCT ID: NCT04309838

Last Updated: 2020-03-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-31
• Study Completion Date: 2021-12-31

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 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• 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

Exclusion Criteria

• contraindications according to package information leaflet (LENUS pro) and/or summary of product characteristics (Treprostinil)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OMT GmbH & Co. KG

UNKNOWN

Sponsor Role: collaborator

University Medicine Greifswald

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DRK Kliniken Berlin Westend

Berlin, , Germany

Uniklinik Köln

Cologne, , Germany

Universitätsklinikum Gießen

Giessen, , Germany

Universitätsmedizin Greifswald

Greifswald, , Germany

Universitätsklinikum Hamburg Eppendorf

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Universitätsklinikum Regensburg

Regensburg, , Germany

Countries

Germany

Central Contacts

Ralf Ewert, Prof. MD

Role: CONTACT

ralf.ewert@med.uni-greifswald.de

+49 3834 86 ext. 80596

Facility Contacts

Christian F Opitz, MD

Role: primary

Stephan Rosenkranz, Prof. MD

Role: primary

Felix Gerhardt, MD

Role: backup

Henning Gall, MD

Role: primary

Manuel Richter, MD

Role: backup

Ralf Ewert, Prof. MD

Role: primary

ralf.ewert@med.uni-greifswald.de

+49 3834 86 ext. 80598

Hans FE Klose, MD

Role: primary

Karen Olsson, MD

Role: primary

Marius M Hoeper, Prof. MD

Role: backup

Ekkehard Grünig, Prof. MD

Role: primary

Tobias Lange, MD

Role: primary

Other Identifiers

LPS-II

Identifier Type: -

Identifier Source: org_study_id