COMPERA / COMPERA-KIDS (COMPERA)
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| ClinicalTrials.gov Identifier: NCT01347216 |
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Recruitment Status :
Recruiting
First Posted : May 4, 2011
Last Update Posted : January 13, 2023
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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 |
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| Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension (PH) |
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 |
| 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 |
- 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 ]
- 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 ]
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.
| 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 |
Inclusion Criteria:
- All age groups (amendment dated 1 June 2013)
- Written informed consent
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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).
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 ClinicalTrials.gov identifier (NCT number): NCT01347216
| 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 |
| Belgium | |
| Dept. of Pneumology, University | Recruiting |
| Leuven, Belgium | |
| Contact: Marion Delcroix, MD, PhD | |
| Principal Investigator: Marion Delcroix, MD, PhD | |
| Germany | |
| 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 | |
| Italy | |
| Department of Cardiovascular and Respiratory Sciences, University La Sapienza | Recruiting |
| Rome, Italy | |
| Contact: Dario Vizza, MD, PhD | |
| Principal Investigator: Dario Vizza, MD, PhD | |
| Switzerland | |
| Dept. for Rheumatology, University Hospital | Recruiting |
| Zurich, Switzerland | |
| Contact: Oliver Distler, MD, PhD | |
| Principal Investigator: Oliver Distler, MD, PhD | |
| 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 |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Technische Universität Dresden |
| ClinicalTrials.gov 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. |
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Drug treatment Treatment pathways Clinical routine Registry Treatment outcomes Endothelin receptor antagonist Phosphodiesterase-V inhibitor Prostanoid Sildenafil Bosentan Macitentan Sitaxentan Ambrisentan Imatinib Epoprostenol |
Treprostinil Iloprost Infusion pump Riociguat soluble guanylate cyclase stimulator Quality of life Patient-related outcomes Economic model Adverse event Safety Combination therapy Internet Europe Eisenmenger Adults |
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Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |