Status:
UNKNOWN
Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
University Medicine Greifswald
Collaborating Sponsors:
OMT GmbH & Co. KG
Conditions:
Pulmonary Arterial Hypertension
PAH
Eligibility:
All Genders
18+ years
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 pulmona...
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 subst...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04309838
Start Date
March 1 2020
End Date
December 1 2021
Last Update
March 16 2020
Active Locations (8)
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1
DRK Kliniken Berlin Westend
Berlin, Germany, 14050
2
Uniklinik Köln
Cologne, Germany, 50937
3
Universitätsklinikum Gießen
Giessen, Germany, 35392
4
Universitätsmedizin Greifswald
Greifswald, Germany, 17489