COMPERA / COMPERA-KIDS

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Technische Universität Dresden
Sponsor:
Collaborator:
GWT-TUD GmbH, Dresden, Germany
Information provided by (Responsible Party):
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT01347216
First received: May 3, 2011
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

In view of the manifold options for mono- and combination therapy that have now emerged for patients with pulmonary (arterial) hypertension (PH/PAH), controlled clinical trials can only provide part of the information needed for optimal management. In order to gather adequate data on PAH/PH treatment in routine clinical care, the ongoing COMPERA registry prospectively documents consecutive patients with newly initiated treatment of PAH/PAH since May 2007. The internet-based registry fulfills high quality standards through several measures (planned minimum centre contribution of at least 10 patients per year, automated plausibility checks of data at entry, queries, monitoring with source data verification in >50% of participating centers). It can be applied, among further purposes, for quality assurance: individual centers can confidentially compare their results with the combined outcome of other centers and the recommendations from guidelines. It is expected that the register contributes to optimization of specific drug therapy for PAH and PH.

Since July 2013, also children of any age can be documented (COMPERA-KIDS).


Condition
Pulmonary Arterial Hypertension (PAH)
Pulmonary Hypertension (PH)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Estimated Enrollment: 6000
Study Start Date: June 2007
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Detailed Description:

COMPERA will report current and comprehensive data on

  • Demographics and clinical course of incident and prevalent PAH and PH patients
  • Patient outcomes including survival, by subgroup, by treatment strategy and other factors
  • Clinical predictors of short-term and long-term clinical outcomes
  • Relationship between PAH medications and patient outcomes
  • Temporal trends in treatments and outcomes for newly diagnosed patients
  • The state of implementation of current PAH guidelines
  • Evolving research needs of the PAH community
  • Patients with PAH associated with congenital heart disease and Eisenmenger physiology who do not receive specific drug therapy for PAH ("COMPERA-Eisenmenger", as stated in the amendment dated 23. January 2012).
  • Children of any age with PH or PAH (all Dana Point groups), as stated in the amendment dated 1 June 2013 ("COMPERA-KIDS").
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with any manifestation of pulmonary hypertension

Criteria

Inclusion Criteria:

  • All age groups (amendment dated 1 June 2013)
  • Written informed consent
  • Pulmonary hypertension (PH) of either

    • PAH: idiopathic form (IPAH) or
    • PAH associated with connective tissue diseases (PAH-CTD), with congenital heart defects (PAH-CHD), with HIV infection (PAH-HIV), or the portopulmonary form
    • Chronic thromboembolic PH (CTEPH)
    • PH in left heart diseases (with isolated diastolic dysfunction; with systolic dysfunction, other)
    • PH in pulmonary disease (chronic obstructive pulmonary disease; interstitial fibrosis, etc.)
    • "Relative PH" in CHD after cavopulmonary anastomosis or Fontan-type surgery, even without the classical pulmonary pressure criteria of PH.
  • Newly initiated (i.e. a maximum of 3 months before documentation for the first time) therapy with ERA, PDE-5 inhibitors or prostacyclins in mono- or combination therapy.

Exceptions: PAH-CHD patients can be included on maintenance or newly initiated PAH therapy (3-month rule dose not apply).

PAH-CHD patients with severe pulmonary vascular disease (e.g. Eisenmenger physiology) irrespective of treatment with any PAH drugs are eligible for inclusion, too.

Exclusion Criteria:

  • Patients on maintenance therapy, i.e. previous treatment with any ERA/ PDE-V-inhibitor/prostacyclin/sGC stimulator drug longer than 3 months before documentation for the first time (exception: PAH-CHD patients).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347216

Contacts
Contact: David Pittrow, MD, PhD. +49351458 ext 2815 david.pittrow@mailbox.tu-dresden.de
Contact: Marius Hoeper, MD, PhD +49511532 ext 3537 Hoeper.Marius@mh-hannover.de

Locations
Belgium
Dept. of Pneumology, University Recruiting
Leuven, Belgium
Contact: Marion Delcroix, MD, PhD         
Principal Investigator: Marion Delcroix, MD, PhD         
Germany
DRK-Klinikum Köpenick Recruiting
Berlin, Germany
Contact: Christian Opitz, MD, PhD         
Principal Investigator: Christian Opitz, MD, PhD         
Lung Centre, University of Giessen Recruiting
Giessen, Germany
Contact: Ardeschir Ghofrani, MD, PhD         
Principal Investigator: Ardeschir Ghofrani, MD         
Sub-Investigator: Melanie Thamm, MD         
Department of Pulmology; Hannover Medical School Recruiting
Hannover, Germany
Contact: Marius M Hoeper         
Principal Investigator: Marius M Hoeper, MD, PhD         
Sub-Investigator: Karen Olsson, MD         
German Heart Centre Recruiting
Munich, Germany
Contact: Harald Kaemmerer, MD,. PhD         
Principal Investigator: Harald Kaemmerer, MD, PhD         
Ireland
Mater Misericordiae Recruiting
Dublin, Ireland
Contact: Sean Gaine, MD, PhD         
Principal Investigator: Sean Gaine, MD, PhD         
Italy
Department of Cardiovascular and Respiratory Sciences, University La Sapienza Recruiting
Rome, Italy
Contact: Dario Vizza, MD, PhD         
Principal Investigator: Dario Vizza, MD, PhD         
Switzerland
Dept. for Rheumatology, University Hospital Recruiting
Zurich, Switzerland
Contact: Oliver Distler, MD, PhD         
Principal Investigator: Oliver Distler, MD, PhD         
Sponsors and Collaborators
Technische Universität Dresden
GWT-TUD GmbH, Dresden, Germany
Investigators
Study Chair: Wilhelm Kirch, MD, PhD Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Principal Investigator: Marius M Hoeper, MD, PhD Department of Pulmonology, Medical School Hannover, Germany
Study Director: Ardeschir Ghofrani, MD, PhD Lung Centre, Giessen, Germany
Study Director: Marion Delcroix, MD, PhD Dept of Pneumology, University Leuven, Belgium
Study Director: Sean Gain, MD, PhD Mater Misercordiae Hospital, Dublin, Ireland
Study Director: Dario Vizza, MD Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy
Study Director: David Pittrow, MD, PhD Institute for Clinical Pharmacoloy, Medical Faculty, Technical University Dresden, Germany
Study Director: Christian Opitz, MD, PhD Department of Cardiology, DRK-Kliniken Berlin, Germany
Study Director: Oliver Distler, MD, PhD Department for Rheumatology, University Hospital Zurich, Switzerland
Study Director: Harald Kaemmerer, MD, PhD German Heart Centre, Munich, Germany
Study Director: Simon R Gibbs, MD Imperial College London, UK
Study Director: Stephan Rosenkranz, MD, PhD Heart Centre, Cologne
Study Director: Ekkehard Grünig, MD, PhD Centre for Pulmonary Hypertension at Thoraxclinic Heidelberg, Germany
Principal Investigator: Matthias Gorenflo, MD, PhD Dept. Paed. Cardiol./Congenital Cardiology, Heidelberg University Medical Centre, Germany
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT01347216     History of Changes
Other Study ID Numbers: COMPERA
Study First Received: May 3, 2011
Last Updated: July 16, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
Drug treatment
Treatment pathways
Clinical routine
Registry
Treatment outcomes
Endothelin receptor antagonist
Phosphodiesterase-V inhibitor
Prostanoid
Sildenafil
Bosentan
Macitentan
Sitaxentan
Ambrisentan
Imatinib
Epoprostenol
Treprostinil
Iloprost
Infusion pump
Riociguat
soluble guanylate cyclase stimulator
Quality of life
Patient-related outcomes
Economic model
Adverse event
Safety
Combination therapy
Internet
Europe
Australia
Japan

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014