NCT04309838

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 16, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 16, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 20, 2020

Last Update Submit

March 12, 2020

Conditions

Pulmonary Arterial HypertensionPAH

Keywords

PAHPulmonary arterial hypertensionTreprostinil

Outcome Measures

Primary Outcomes (1)

  • Recovery of clinical stability criteria

    to achieve "low-risk-status"

    Baseline and after 6 months intravenous therapy with Treprostinil

Secondary Outcomes (3)

  • Quality of Life

    Baseline and after 6 months intravenous therapy with Treprostinil

  • Restrictions caused by the implant

    immediately after implantation until 6 months intravenous therapy with Treprostinil

  • Polysomnography

    Baseline and after 6 months intravenous therapy with Treprostinil

Other Outcomes (1)

  • Adverse Events associated with the implant

    at any visit

Interventions

Treprostinil via implanted pumpCOMBINATION_PRODUCT

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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

You may not qualify if:

  • contraindications according to package information leaflet (LENUS pro) and/or summary of product characteristics (Treprostinil)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

DRK Kliniken Berlin Westend

Berlin, 14050, Germany

Location

Uniklinik Köln

Cologne, 50937, Germany

Location

Universitätsklinikum Gießen

Giessen, 35392, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17489, Germany

Location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69126, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Ralf Ewert, Prof. MD

CONTACT

+49 3834 86ralf.ewert@med.uni-greifswald.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2020

First Posted

March 16, 2020

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

December 1, 2021

Last Updated

March 16, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(8)