Pulmonary Arterial Hypertension Clinical Trial
— LPS-IIOfficial title:
LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension
NCT number | NCT04309838 |
Other study ID # | LPS-II |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 2020 |
Est. completion date | December 2021 |
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).
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
University Medicine Greifswald | OMT GmbH & Co. KG |
Germany,
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 |
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