COMPERA / COMPERA-KIDS

This study is currently recruiting participants.
Verified November 2013 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: November 7, 2013
Last verified: November 2013

May 3, 2011
November 7, 2013
June 2007
May 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01347216 on ClinicalTrials.gov Archive Site
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COMPERA / COMPERA-KIDS
Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension

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).

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").
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients with any manifestation of pulmonary hypertension

  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Hypertension (PH)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
May 2015
May 2015   (final data collection date for primary outcome measure)

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 Eisenmenger physiology with or without PAH drugs are eligible for inclusion, too.

Exclusion Criteria:

  • Patients on maintenance therapy, i.e. previous treatment with any ERA/PDE-V-inhibitor/prostacyclin longer than 3 months before documentation for the first time (exception: PAH-CHD patients).
Both
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No
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
Belgium,   Germany,   Ireland,   Italy,   Switzerland
 
NCT01347216
COMPERA
Yes
Technische Universität Dresden
Technische Universität Dresden
GWT-TUD GmbH, Dresden, Germany
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
Technische Universität Dresden
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP