Pulmonary Hypertension Group 1 and 4 According to Nice ClassificationNCT01977014
NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up
An observational study of Pulmonary Hypertension Group 1 and 4 According to Nice Classification, run by NordicInfu Care AB at 8 sites in 3 countries.
Trial summary
This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Hypertension Group 1 and 4 According to Nice Classification
- How many people
- 40 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Oct 2013to Dec 2016
- How long will I take part?
- 4 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in Scandinavia who received a LenusPro pump
Who may be able to join
- The patient should have been diagnosed with Pulmonary Arterial Hypertension
- The patient has received or will receive treatment with the implanted pump LenusPro
Who cannot join
- The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Sweden4 sites
Department of Cardiology University Hospital in Linköping
Linköping, 581 85
Skane Univerity Hospital, Lund
Lund, 221 85
Karolinska Univerity Hospital, Solna
Stockholm, 171 76
Department of Cardiology Uppsala Akademiska University Hospital
Uppsala, 75185
Denmark2 sites
Department of Cardiology, Aarhus University Hospital, Skejby
Aarhus, 8200
Department of Cardiology Rigshospitalet University Hospital
Copenhagen
Norway2 sites
Department of Cardiology Oslo University Hospital, Rikshospitalet
Oslo, 0424
Department of Cardiology, St Olav University Hospital
Trondheim, 7006
About this study
This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment.
Participating centres are located in Denmark, Norway and Sweden.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with LenusPro pump | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and severity of events reported for the Lenus Pro in a clinical environment.
Measured: Up to 3,5 years
Changes in baseline variables during follow-up on quality of life.
Patient reported outcome measures, mainly CAMPHOR and SF-36
Measured: Up to 3,5 years
Secondary outcomes (1)
Description of baseline and follow-up of hemodynamic and functional capacity.
Mainly right hearth catheterization, echo and 6MWD data.
Measured: Up to 3,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Hypertension Group 1 and 4 According to Nice ClassificationStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- NordicInfu Care AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jorn Carlsen, MD, Principal investigator, Department of Cardiology, Rigshospitalet in CopenhagenGerhard Vikstrom, MD, Principal investigator, Department of Cardiology, Uppsala Akademiska University HospitalArne Andreassen, MD, Principal investigator, Department of Cardiology, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977014
- Sponsor's protocol ID
- NIMS/PAH/LP/001
- Status last verified
- Jul 2017
- First submitted
- 22 Oct 2013
- Last updated
- 7 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up
- ClinicalTrials.gov ID
- NCT01977014
- Acronym / sponsor ID
- NIMS/PAH/LP/001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NordicInfu Care ABIndustry (pharma, biotech, devices)
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Nov 2013 (estimated)
- 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.
This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment.
Participating centres are located in Denmark, Norway and Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with LenusPro pump | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in Scandinavia who received a LenusPro pump
Key inclusion criteria (2 listed)
- The patient should have been diagnosed with Pulmonary Arterial Hypertension
- The patient has received or will receive treatment with the implanted pump LenusPro
Key exclusion criteria (1 listed)
- The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number and severity of events reported for the Lenus Pro in a clinical environment.
Time frame: Up to 3,5 years
Changes in baseline variables during follow-up on quality of life.
Time frame: Up to 3,5 years
Patient reported outcome measures, mainly CAMPHOR and SF-36
1 secondary outcome
Description of baseline and follow-up of hemodynamic and functional capacity.
Time frame: Up to 3,5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2017.
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.
Jorn Carlsen, MD principal investigator
Department of Cardiology, Rigshospitalet in Copenhagen
Gerhard Vikstrom, MD principal investigator
Department of Cardiology, Uppsala Akademiska University Hospital
Arne Andreassen, MD principal investigator
Department of Cardiology, Oslo University Hospital
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension Group 1 and 4 According to Nice Classification, run by NordicInfu Care AB at 8 sites in 3 countries.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 7 Jul 2017. 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 Sweden, Denmark, Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and severity of events reported for the Lenus Pro in a clinical environment. (time frame: Up to 3,5 years). The study lists 2 primary outcomes in all. 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 7 Jul 2017.