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COMPERA / COMPERA-KIDS (COMPERA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01347216
Recruitment Status : Recruiting
First Posted : May 4, 2011
Last Update Posted : January 13, 2023
Sponsor:
Collaborator:
GWT-TUD GmbH
Information provided by (Responsible Party):
Technische Universität Dresden

Tracking Information
First Submitted Date May 3, 2011
First Posted Date May 4, 2011
Last Update Posted Date January 13, 2023
Actual Study Start Date July 1, 2007
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 31, 2017)		 Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns) [ Time Frame: Up to 10 years after inclusion ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: July 31, 2017)
  • Number of patients in the various Dana Point groups (patient characteristics in PAH and non-PAH pulmonary hypertension groups) [ Time Frame: Up to 10 years after inclusion ]
  • Probability of survival in the various Dana Point groups (PAH and non-PAH pulmonary hypertension groups) by Kaplan-Meier estimate [ Time Frame: Up to 10 years after inclusion ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COMPERA / COMPERA-KIDS
Official Title Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension
Brief Summary

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).
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").
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with any manifestation of pulmonary hypertension
Condition
  • Pulmonary Arterial Hypertension (PAH)
  • Pulmonary Hypertension (PH)
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 19, 2022)		 12000
Original Estimated Enrollment
 (submitted: May 3, 2011)		 3000
Estimated Study Completion Date January 1, 2025
Estimated Primary Completion Date January 1, 2025   (Final data collection date for primary outcome measure)
Eligibility 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 endothelin receptor antagonists (ERA), phoshodiesterase-5 (PDE-5) inhibitors, soluble guanylate cyclase (sGC) stimulators 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-5 inhibitor/prostacyclin/sGC stimulator drug longer than 3 months before documentation for the first time (exception: PAH-CHD patients).
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Week and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: David Pittrow, MD, PhD +498152 ext 9989803 david.pittrow@mailbox.tu-dresden.de
Contact: Marius M. Hoeper, MD, PhD +49511532 ext 3537 Hoeper.Marius@mh-hannover.de
Listed Location Countries Belgium,   Germany,   Italy,   Switzerland
Removed Location Countries Ireland
 
Administrative Information
NCT Number NCT01347216
Other Study ID Numbers COMPERA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Data sharing has not been planned.
Current Responsible Party Technische Universität Dresden
Original Responsible Party GWT-TUD GmbH, Gesellschaft für Wissenschaftstransfer der TUD
Current Study Sponsor Technische Universität Dresden
Original Study Sponsor Same as current
Collaborators GWT-TUD GmbH
Investigators
Principal Investigator: Marius M Hoeper, MD, PhD Department of Pulmonology, Medical School Hannover, Germany
Study Director: Ardeschir H. Ghofrani, MD, PhD Lung Centre, Giessen, Germany
Study Director: Marion Delcroix, MD, PhD Dept of Pneumology, University Leuven, Belgium
Study Director: Dario Vizza, MD, PhD 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
Study Director: Karen Olsson, MD, PhD Department of Pulmonology, Medical School Hannove
PRS Account Technische Universität Dresden
Verification Date January 2023