NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up

July 5, 2017 updated by: NordicInfu Care AB

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Department of Cardiology, Aarhus University Hospital, Skejby
      • Copenhagen, Denmark
        • Department of Cardiology Rigshospitalet University Hospital
  • Norway
      • Oslo, Norway, 0424
        • Department of Cardiology Oslo University Hospital, Rikshospitalet
      • Trondheim, Norway, 7006
        • Department of Cardiology, St Olav University Hospital
  • Sweden
      • Linköping, Sweden, 581 85
        • Department of Cardiology University Hospital in Linköping
      • Lund, Sweden, 221 85
        • Skane Univerity Hospital, Lund
      • Stockholm, Sweden, 171 76
        • Karolinska Univerity Hospital, Solna
      • Uppsala, Sweden, 75185
        • Department of Cardiology Uppsala Akademiska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in Scandinavia who received a LenusPro pump

Description

Inclusion Criteria:

  • The patient should have been diagnosed with Pulmonary Arterial Hypertension
  • The patient has received or will receive treatment with the implanted pump LenusPro

Exclusion Criteria:

  • The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient with LenusPro pump

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and severity of events reported for the Lenus Pro in a clinical environment.
Time Frame: Up to 3,5 years
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
Up to 3,5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of baseline and follow-up of hemodynamic and functional capacity.
Time Frame: Up to 3,5 years
Mainly right hearth catheterization, echo and 6MWD data.
Up to 3,5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NordicInfu Care AB

Investigators

  • Principal Investigator: Jorn Carlsen, MD, Department of Cardiology, Rigshospitalet in Copenhagen
  • Principal Investigator: Gerhard Vikstrom, MD, Department of Cardiology, Uppsala Akademiska University Hospital
  • Principal Investigator: Arne Andreassen, MD, Department of Cardiology, Oslo University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

October 22, 2013

First Submitted That Met QC Criteria

October 30, 2013

First Posted (ESTIMATE)

November 6, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 7, 2017

Last Update Submitted That Met QC Criteria

July 5, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMS/PAH/LP/001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pulmonary Hypertension Group 1 and 4 According to Nice Classification

  • Actelion
    Active, not recruiting
    Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)
    Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)
    United States, Japan, Taiwan, Turkey, Canada, China, Germany, Spain, Italy, Malaysia, Hungary, Russian Federation, Brazil, Australia, Bulgaria, Czechia, Mexico, Poland, South Africa
  • University of Kansas Medical Center
    Recruiting
    Pulmonary Hypertension Biorepository and Registry (PHBR)
    Pulmonary Arterial Hypertension | Pulmonary Hypertension | Chronic Thromboembolic Pulmonary Hypertension | Pulmonary Hypertension Due to Left Heart Disease | Pulmonary Hypertension, Primary, 4 | Pulmonary Hypertension, Primary, 2 | Pulmonary Hypertension, Primary, 3 | Pulmonary Hypertension, Primary and other conditions
    United States
  • Assiut University
    Not yet recruiting
    Phenotyping of the Out-of-proportion Pulmonary Hypertension
    1- Haemodynamic Phenotyping of the Out - of - Proportion PH to Guide Different Therapeutic Lines
    Egypt
  • Corporal Michael J. Crescenz VA Medical Center
    Completed
    Study of Default Options in Advance Directives
    Idiopathic Pulmonary Fibrosis | COPD | Congestive Heart Failure | Malignancy | Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy | Other Interstitial Lung Disease Without Curative Therapy | NYHA Class IV or NYHA Class III Plus 1 Hospitalization... and other conditions
    United States
  • RTI International
    Eunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaborators
    Enrolling by invitation
    Early Check: Expanded Screening in Newborns
    Primary Hyperoxaluria Type 3 | Diabetes Mellitus | Hemophilia A | Hemophilia B | Hereditary Fructose Intolerance | Cystic Fibrosis | Factor VII Deficiency | Phenylketonurias | Sickle Cell Disease | Dravet Syndrome | Duchenne Muscular Dystrophy | Prader-Willi Syndrome | Fragile X Syndrome | Chronic Granulomatous Disease and other conditions
    United States

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe