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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. Identifier: NCT01347216
Recruitment Status : Recruiting
First Posted : May 4, 2011
Last Update Posted : January 13, 2023
Information provided by (Responsible Party):
Technische Universität Dresden

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).

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

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").

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension
Actual Study Start Date : July 1, 2007
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : January 1, 2025

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Week and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with any manifestation of pulmonary hypertension

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01347216

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Contact: David Pittrow, MD, PhD +498152 ext 9989803
Contact: Marius M. Hoeper, MD, PhD +49511532 ext 3537

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Dept. of Pneumology, University Recruiting
Leuven, Belgium
Contact: Marion Delcroix, MD, PhD         
Principal Investigator: Marion Delcroix, MD, PhD         
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         
Department of Cardiovascular and Respiratory Sciences, University La Sapienza Recruiting
Rome, Italy
Contact: Dario Vizza, MD, PhD         
Principal Investigator: Dario Vizza, MD, PhD         
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
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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
Publications of Results:
Kaemmerer H, Gorenflo M, Huscher D, Pittrow D, Apitz C, Baumgartner H, Berger F, Bruch L, Brunnemer E, Budts W, Claussen M, Coghlan G, Dahnert I, D'Alto M, Delcroix M, Distler O, Dittrich S, Dumitrescu D, Ewert R, Faehling M, Germund I, Ghofrani HA, Grohe C, Grossekreymborg K, Halank M, Hansmann G, Harzheim D, Nemes A, Havasi K, Held M, Hoeper MM, Hofbeck M, Hohenfrost-Schmidt W, Jureviciene E, Gumbiene L, Kabitz HJ, Klose H, Kohler T, Konstantinides S, Koestenberger M, Kozlik-Feldmann R, Kramer HH, Kropf-Sanchen C, Lammers A, Lange T, Meyn P, Miera O, Milger-Kneidinger K, Neidenbach R, Neurohr C, Opitz C, Perings C, Remppis BA, Riemekasten G, Scelsi L, Scholtz W, Simkova I, Skowasch D, Skride A, Stahler G, Stiller B, Tsangaris I, Vizza CD, Vonk Noordegraaf A, Wilkens H, Wirtz H, Diller GP, Grunig E, Rosenkranz S. Pulmonary Hypertension in Adults with Congenital Heart Disease: Real-World Data from the International COMPERA-CHD Registry. J Clin Med. 2020 May 13;9(5):1456. doi: 10.3390/jcm9051456.

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Technische Universität Dresden Identifier: NCT01347216    
Other Study ID Numbers: COMPERA
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data sharing has not been planned.
Keywords provided by Technische Universität Dresden:
Drug treatment
Treatment pathways
Clinical routine
Treatment outcomes
Endothelin receptor antagonist
Phosphodiesterase-V inhibitor
Infusion pump
soluble guanylate cyclase stimulator
Quality of life
Patient-related outcomes
Economic model
Adverse event
Combination therapy
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases