COMPERA / COMPERA-KIDS (COMPERA)

August 22, 2025 updated by: Technische Universität Dresden

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).

Study Overview

Status

Recruiting

Conditions

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

Enrollment (Estimated)

14000

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium
        • Recruiting
        • Dept. of Pneumology, University
        • Contact:
          • Marion Delcroix, MD, PhD
        • Principal Investigator:
          • Marion Delcroix, MD, PhD
  • Germany
      • Berlin, Germany
        • Recruiting
        • DRK-Klinikum Köpenick
        • Contact:
          • Christian Opitz, MD, PhD
        • Principal Investigator:
          • Christian Opitz, MD, PhD
      • Giessen, Germany
        • Recruiting
        • Lung Centre, University of Giessen
        • Contact:
          • Ardeschir Ghofrani, MD, PhD
        • Principal Investigator:
          • Ardeschir Ghofrani, MD
        • Sub-Investigator:
          • Melanie Thamm, MD
      • Hannover, Germany
        • Recruiting
        • Department of Pulmology; Hannover Medical School
        • Contact:
          • Marius M Hoeper
        • Principal Investigator:
          • Marius M Hoeper, MD, PhD
        • Sub-Investigator:
          • Karen Olsson, MD
      • Munich, Germany
        • Recruiting
        • German Heart Centre
        • Contact:
          • Harald Kaemmerer, MD,. PhD
        • Principal Investigator:
          • Harald Kaemmerer, MD, PhD
  • Italy
      • Rome, Italy
        • Recruiting
        • Department of Cardiovascular and Respiratory Sciences, University La Sapienza
        • Contact:
          • Dario Vizza, MD, PhD
        • Principal Investigator:
          • Dario Vizza, MD, PhD
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • Dept. for Rheumatology, University Hospital
        • Contact:
          • Oliver Distler, MD, PhD
        • Principal Investigator:
          • Oliver Distler, MD, PhD

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

1 week and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with any manifestation of pulmonary hypertension

Description

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).

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 10 years after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Up to 10 years after inclusion

Collaborators and Investigators

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

Sponsor

Technische Universität Dresden

Collaborators

GWT-TUD GmbH

Investigators

  • Principal Investigator: Marius M Hoeper, MD, PhD, Department of Pulmonology, Medical School Hannover, Germany
  • Study Director: Marion Delcroix, MD, PhD, Dept of Pneumology, University Leuven, Belgium
  • 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: 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: Ardeschir H. Ghofrani, MD, PhD, Lung Centre, Giessen, Germany
  • Study Director: Dario Vizza, MD, PhD, Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy
  • Study Director: Karen Olsson, MD, PhD, Department of Pulmonology, Medical School Hannove

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

July 1, 2007

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 3, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (Estimated)

May 4, 2011

Study Record Updates

Last Update Posted (Actual)

August 24, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMPERA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data sharing has not been planned.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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