Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA)
This study is currently recruiting participants.
Verified April 2013 by Dresden University of Technology
Sponsor:
Dresden University of Technology
Collaborator:
GWT-TUD GmbH, Dresden, Germany
Information provided by (Responsible Party):
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT01347216
First received: May 3, 2011
Last updated: April 29, 2013
Last verified: April 2013
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Purpose
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.
| Condition |
|---|
|
Pulmonary Arterial Hypertension (PAH) Pulmonary Hypertension (PH) |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension |
Resource links provided by NLM:
Further study details as provided by Dresden University of Technology:
| Estimated Enrollment: | 4500 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with any manifestation of pulmonary hypertension
Criteria
Inclusion Criteria:
- Age 18 years or above
- 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 ERA, PDE-5 inhibitors or prostacyclins in mono- or combination therapy.
Exception: PAH-CHD patients can be included with and without PAH specific drug therapy.
Exclusion Criteria:
- Patients on maintenance therapy, i.e. previous treatment with any ERA/PDE-V-inhibitor/prostacyclin longer than 3 months before documentation for the first time (exception: PAH-CHD patients).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01347216
Contacts
| Contact: David Pittrow, MD, PhD. | +49351458 ext 2815 | david.pittrow@mailbox.tu-dresden.de |
| Contact: Marius Hoeper, MD, PhD | +49511532 ext 3537 | Hoeper.Marius@mh-hannover.de |
Locations
| 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 | |
| Ireland | |
| Mater Misericordiae | Recruiting |
| Dublin, Ireland | |
| Contact: Sean Gaine, MD, PhD | |
| Principal Investigator: Sean Gaine, 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 | |
Sponsors and Collaborators
Dresden University of Technology
GWT-TUD GmbH, Dresden, Germany
Investigators
| Study Chair: | Wilhelm Kirch, MD, PhD | Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany |
| Principal Investigator: | Marius M Hoeper, MD, PhD | Department of Pulmonology, Medical School Hannover, Germany |
| Study Director: | Ardeschir Ghofrani, MD, PhD | Lung Centre, Giessen, Germany |
| Study Director: | Marion Delcroix, MD, PhD | Dept of Pneumology, University Leuven, Belgium |
| Study Director: | Sean Gain, MD, PhD | Mater Misercordiae Hospital, Dublin, Ireland |
| Study Director: | Dario Vizza, MD | 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 |
More Information
Publications:
| Responsible Party: | Dresden University of Technology |
| ClinicalTrials.gov Identifier: | NCT01347216 History of Changes |
| Other Study ID Numbers: | COMPERA |
| Study First Received: | May 3, 2011 |
| Last Updated: | April 29, 2013 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Dresden University of Technology:
|
Drug treatment Treatment pathways Clinical routine Registry Treatment outcomes Endothelin receptor antagonist Phosphodiesterase-V inhibitor Prostanoid Sildenafil Bosentan Sitaxentan Ambrisentan Imatinib Epoprostenol |
Treprostinil Iloprost Riociguat Quality of life Patient-related outcomes Economic model Adverse event Safety Combination therapy Internet Europe Australia Japan Eisenmenger |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013