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

Pulmonary Arterial Hypertension Clinical Trial

— LPS-II  

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04309838
• Other study ID #: LPS-II
• Status: Not yet recruiting
• Start date: March 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: University Medicine Greifswald
• Contact: Ralf Ewert, Prof. MD
• Phone: +49 3834 86
• Email: ralf.ewert[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Observational

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• PAH
• Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
Germany	DRK Kliniken Berlin Westend	Berlin
Germany	Universitätsklinikum Gießen	Gießen
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Universitätsklinikum Hamburg Eppendorf	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	Uniklinik Köln	Köln
Germany	Universitätsklinikum Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
University Medicine Greifswald	OMT GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse Events associated with the implant	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	at any visit
Primary	Recovery of clinical stability criteria	to achieve "low-risk-status"	Baseline and after 6 months intravenous therapy with Treprostinil
Secondary	Quality of Life	Assessment of Quality of Life by EQ-5D-5F questionnaire (patient reported)	Baseline and after 6 months intravenous therapy with Treprostinil
Secondary	Restrictions caused by the implant	Assessment of restrictions that may cause by the implant: mobility, pain, rubor, swelling	immediately after implantation until 6 months intravenous therapy with Treprostinil
Secondary	Polysomnography	Record of hypnogram: duration of sleep, respiratory analysis, quantity and severity of apnea and hypopnea, snoring, oxygen saturation, heart rate, Continuous Positive Airway Pressure	Baseline and after 6 months intravenous therapy with Treprostinil