Pulmonary Arterial HypertensionLPS-IINCT04309838
Observation Study With Implantable Medication Pump for Intravenous Treprostinil Therapy in Patients With Pulmonary Arterial Hypertension
An observational study of Pulmonary Arterial Hypertension and PAH, run by University Medicine Greifswald at 8 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension, PAH
- What is being tested?
- Treprostinil via implanted pump
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 8 sitesGermany
- Study dates
- Mar 2020to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with PAH (Pulmonary arterial hypertension) who need to undergo treatment with Treprostinil, administered by an intravenous pump system (LENUS pro)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Germany8 sites
DRK Kliniken Berlin Westend
Berlin, 14050
Christian F Opitz, MD
Uniklinik Köln
Cologne, 50937
Stephan Rosenkranz, Prof. MD
Felix Gerhardt, MD
Universitätsklinikum Gießen
Giessen, 35392
Henning Gall, MD
Manuel Richter, MD
Universitätsmedizin Greifswald
Greifswald, 17489
Ralf Ewert, Prof. MD, +49 3834 86 ext. 80598, ralf.ewert@med.uni-greifswald.de
Universitätsklinikum Hamburg Eppendorf
Hamburg, 20246
Hans FE Klose, MD
Medizinische Hochschule Hannover
Hanover, 30625
Karen Olsson, MD
Marius M Hoeper, Prof. MD
Universitätsklinikum Heidelberg
Heidelberg, 69126
Ekkehard Grünig, Prof. MD
Universitätsklinikum Regensburg
Regensburg, 93053
Tobias Lange, MD
About this study
Official title: LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension
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).
Read the 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.
- Conditions
- Pulmonary Arterial Hypertension, PAH
- Being tested
- Treprostinil via implanted pump
- Keywords
- PAH, Pulmonary arterial hypertension, Treprostinil
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of clinical stability criteria
to achieve "low-risk-status"
Measured: Baseline and after 6 months intravenous therapy with Treprostinil
Secondary outcomes (3)
Quality of Life
Assessment of Quality of Life by EQ-5D-5F questionnaire (patient reported)
Measured: Baseline and after 6 months intravenous therapy with Treprostinil
Restrictions caused by the implant
Assessment of restrictions that may cause by the implant: mobility, pain, rubor, swelling
Measured: immediately after implantation until 6 months intravenous therapy with Treprostinil
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
Measured: Baseline and after 6 months intravenous therapy with Treprostinil
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study startMar 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Collaborators
- OMT GmbH & Co. KG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309838
- Sponsor's protocol ID
- LPS-II
- Acronym
- LPS-II
- Status last verified
- Mar 2020
- First submitted
- 20 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LENUS Pro® Study (LPS-II) - Observation Study With Implantable Medication Pump for Intravenous REMODULIN® (Treprostinil) Therapy in Patients With Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT04309838
- Acronym / sponsor ID
- LPS-II / LPS-II
- Conditions
- Pulmonary Arterial Hypertension, PAH
- Keywords
- PAH, Pulmonary arterial hypertension, Treprostinil
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Collaborators
- OMT GmbH & Co. KG
- Study start
- Mar 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with PAH (Pulmonary arterial hypertension) who need to undergo treatment with Treprostinil, administered by an intravenous pump system (LENUS pro)
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treprostinil via implanted pumpPatients, 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. | Combination product | – |
Primary outcome
Recovery of clinical stability criteria
Time frame: Baseline and after 6 months intravenous therapy with Treprostinil
to achieve "low-risk-status"
3 secondary outcomes
Quality of Life
Time frame: 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
Polysomnography
Time frame: Baseline and after 6 months intravenous therapy with Treprostinil
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Arterial Hypertension and PAH, run by University Medicine Greifswald at 8 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ralf Ewert, Prof. MD (+49 3834 86 ext. 80596, ralf.ewert@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of clinical stability criteria (time frame: Baseline and after 6 months intravenous therapy with Treprostinil). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2020.