PAH, Pulmonary Arterial Hypertension
Conditions
Keywords
PAH, Pulmonary arterial hypertension, Treprostinil
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 pulmonary arterial hypertension (PAH).
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.
Interventions
COMBINATION_PRODUCTTreprostinil 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.
Sponsors
OMT GmbH & Co. KG
University Medicine Greifswald
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of clinical stability criteria | Baseline and after 6 months intravenous therapy with Treprostinil | to achieve low-risk-status |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life | Baseline and after 6 months intravenous therapy with Treprostinil | Assessment of Quality of Life by EQ-5D-5F questionnaire (patient reported) |
| Restrictions caused by the implant | immediately after implantation until 6 months intravenous therapy with Treprostinil | Assessment of restrictions that may cause by the implant: mobility, pain, rubor, swelling |
| Polysomnography | Baseline and after 6 months intravenous therapy with Treprostinil | Record of hypnogram: duration of sleep, respiratory analysis, quantity and severity of apnea and hypopnea, snoring, oxygen saturation, heart rate, Continuous Positive Airway Pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events associated with the implant | at any visit | 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 |
Countries
Germany
Contacts
Primary ContactRalf Ewert, Prof. MD
Outcome results
None listed