COMPERA / COMPERA-KIDS

NCT ID: NCT01347216

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 14000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-07-01
• Study Completion Date: 2026-12-31

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").

Conditions

Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension (PH)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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).

• Minimum Eligible Age: 1 Week
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GWT-TUD GmbH

OTHER

Sponsor Role: collaborator

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marius M Hoeper, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Pulmonology, Medical School Hannover, Germany

Ardeschir H. Ghofrani, MD, PhD

Role: STUDY_DIRECTOR

Lung Centre, Giessen, Germany

Marion Delcroix, MD, PhD

Role: STUDY_DIRECTOR

Dept of Pneumology, University Leuven, Belgium

Dario Vizza, MD, PhD

Role: STUDY_DIRECTOR

Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy

David Pittrow, MD, PhD

Role: STUDY_DIRECTOR

Institute for Clinical Pharmacoloy, Medical Faculty, Technical University Dresden, Germany

Christian Opitz, MD, PhD

Role: STUDY_DIRECTOR

Department of Cardiology, DRK-Kliniken Berlin, Germany

Oliver Distler, MD, PhD

Role: STUDY_DIRECTOR

Department for Rheumatology, University Hospital Zurich, Switzerland

Harald Kaemmerer, MD, PhD

Role: STUDY_DIRECTOR

German Heart Centre, Munich, Germany

Stephan Rosenkranz, MD, PhD

Role: STUDY_DIRECTOR

Heart Centre, Cologne

Ekkehard Grünig, MD, PhD

Role: STUDY_DIRECTOR

Centre for Pulmonary Hypertension at Thoraxclinic Heidelberg, Germany

Matthias Gorenflo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. Paed. Cardiol./Congenital Cardiology, Heidelberg University Medical Centre, Germany

Karen Olsson, MD, PhD

Role: STUDY_DIRECTOR

Department of Pulmonology, Medical School Hannove

Locations

Dept. of Pneumology, University

Leuven, , Belgium

Site Status: RECRUITING

DRK-Klinikum Köpenick

Berlin, , Germany

Site Status: RECRUITING

Lung Centre, University of Giessen

Giessen, , Germany

Site Status: RECRUITING

Department of Pulmology; Hannover Medical School

Hanover, , Germany

Site Status: RECRUITING

German Heart Centre

Munich, , Germany

Site Status: RECRUITING

Department of Cardiovascular and Respiratory Sciences, University La Sapienza

Rome, , Italy

Site Status: RECRUITING

Dept. for Rheumatology, University Hospital

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Belgium; Germany; Italy; Switzerland

Central Contacts

David Pittrow, MD, PhD

Role: CONTACT

david.pittrow@mailbox.tu-dresden.de

+498152 ext. 9989803

Marius M. Hoeper, MD, PhD

Role: CONTACT

Hoeper.Marius@mh-hannover.de

+49511532 ext. 3537

Facility Contacts

Marion Delcroix, MD, PhD

Role: primary

Christian Opitz, MD, PhD

Role: primary

Ardeschir Ghofrani, MD, PhD

Role: primary

Marius M Hoeper

Role: primary

Harald Kaemmerer, MD,. PhD

Role: primary

Dario Vizza, MD, PhD

Role: primary

Oliver Distler, MD, PhD

Role: primary

References

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Related Links

https://www.compera.org/

COMPERA website

Other Identifiers

COMPERA

Identifier Type: -

Identifier Source: org_study_id