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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Berlin, Germany, 14050
- DRK Kliniken Berlin Westend
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Gießen, Germany, 35392
- Universitätsklinikum Gießen
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Greifswald, Germany, 17489
- Universitätsmedizin Greifswald
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Hamburg, Germany, 20246
- Universitatsklinikum Hamburg Eppendorf
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Hannover, Germany, 30625
- Medizinische Hochschule Hannover
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Heidelberg, Germany, 69126
- Universitatsklinikum Heidelberg
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Köln, Germany, 50937
- Uniklinik Köln
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Regensburg, Germany, 93053
- Universitätsklinikum Regensburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
Time Frame: Baseline and after 6 months intravenous therapy with Treprostinil
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to achieve "low-risk-status"
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Baseline and after 6 months intravenous therapy with Treprostinil
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life
Time Frame: Baseline and after 6 months intravenous therapy with Treprostinil
|
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
Time Frame: immediately after implantation until 6 months intravenous therapy with Treprostinil
|
Assessment of restrictions that may cause by the implant: mobility, pain, rubor, swelling
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immediately after implantation until 6 months intravenous therapy with Treprostinil
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Polysomnography
Time Frame: Baseline and after 6 months intravenous therapy with Treprostinil
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Record of hypnogram: duration of sleep, respiratory analysis, quantity and severity of apnea and hypopnea, snoring, oxygen saturation, heart rate, Continuous Positive Airway Pressure
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Baseline and after 6 months intravenous therapy with Treprostinil
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adverse Events associated with the implant
Time Frame: at any visit
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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
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at any visit
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LPS-II
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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