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

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).

Study Overview

• Status: Unknown
• Conditions: Pulmonary Arterial Hypertension; PAH
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • DRK Kliniken Berlin Westend
  • Gießen, Germany, 35392
    • Universitätsklinikum Gießen
  • Greifswald, Germany, 17489
    • Universitätsmedizin Greifswald
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg Eppendorf
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover
  • Heidelberg, Germany, 69126
    • Universitätsklinikum Heidelberg
  • Köln, Germany, 50937
    • Uniklinik Koln
  • Regensburg, Germany, 93053
    • Universitätsklinikum Regensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with PAH (Pulmonary arterial hypertension) who need to undergo treatment with Treprostinil, administered by an intravenous pump system (LENUS pro)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of clinical stability criteria	to achieve "low-risk-status"	Baseline and after 6 months intravenous therapy with Treprostinil

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Assessment of Quality of Life by EQ-5D-5F questionnaire (patient reported)	Baseline and after 6 months intravenous therapy with Treprostinil
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Medicine Greifswald
• Collaborators: OMT GmbH & Co. KG

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: February 20, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Pulmonary arterial hypertension; PAH; Treprostinil
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Antihypertensive Agents; Treprostinil
• Other Study ID Numbers: LPS-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No