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COMPERA / COMPERA-KIDS

Information source: Technische Universitšt Dresden
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Arterial Hypertension (PAH); Pulmonary Hypertension (PH)

Phase: N/A

Status: Recruiting

Sponsored by: Technische Universitšt Dresden

Official(s) and/or principal investigator(s):
Wilhelm Kirch, MD, PhD, Study Chair, Affiliation: Institute for Clinical Pharmacology, Medical Faculty, Technical University Dresden, Germany
Marius M Hoeper, MD, PhD, Principal Investigator, Affiliation: Department of Pulmonology, Medical School Hannover, Germany
Ardeschir Ghofrani, MD, PhD, Study Director, Affiliation: Lung Centre, Giessen, Germany
Marion Delcroix, MD, PhD, Study Director, Affiliation: Dept of Pneumology, University Leuven, Belgium
Sean Gain, MD, PhD, Study Director, Affiliation: Mater Misercordiae Hospital, Dublin, Ireland
Dario Vizza, MD, Study Director, Affiliation: Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy
David Pittrow, MD, PhD, Study Director, Affiliation: Institute for Clinical Pharmacoloy, Medical Faculty, Technical University Dresden, Germany
Christian Opitz, MD, PhD, Study Director, Affiliation: Department of Cardiology, DRK-Kliniken Berlin, Germany
Oliver Distler, MD, PhD, Study Director, Affiliation: Department for Rheumatology, University Hospital Zurich, Switzerland
Harald Kaemmerer, MD, PhD, Study Director, Affiliation: German Heart Centre, Munich, Germany
Simon R Gibbs, MD, Study Director, Affiliation: Imperial College London, UK
Stephan Rosenkranz, MD, PhD, Study Director, Affiliation: Heart Centre, Cologne
Ekkehard Gr√ľnig, MD, PhD, Study Director, Affiliation: Centre for Pulmonary Hypertension at Thoraxclinic Heidelberg, Germany
Matthias Gorenflo, MD, PhD, Principal Investigator, Affiliation: Dept. Paed. Cardiol./Congenital Cardiology, Heidelberg University Medical Centre, Germany

Overall contact:
David Pittrow, MD, PhD., Phone: +49351458, Ext: 2815, Email: david.pittrow@mailbox.tu-dresden.de

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).

Clinical Details

Official title: Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension

Study design: Observational Model: Cohort, Time Perspective: Prospective

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").

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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 ERA, PDE-5 inhibitors 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-V-inhibitor/prostacyclin/sGC stimulator drug longer than 3 months before documentation for the first time (exception: PAH-CHD patients).

Locations and Contacts

David Pittrow, MD, PhD., Phone: +49351458, Ext: 2815, Email: david.pittrow@mailbox.tu-dresden.de

Dept. of Pneumology, University, Leuven, Belgium; Recruiting
Marion Delcroix, MD, PhD
Marion Delcroix, MD, PhD, Principal Investigator

DRK-Klinikum Köpenick, Berlin, Germany; Recruiting
Christian Opitz, MD, PhD
Christian Opitz, MD, PhD, Principal Investigator

Lung Centre, University of Giessen, Giessen, Germany; Recruiting
Ardeschir Ghofrani, MD, PhD
Ardeschir Ghofrani, MD, Principal Investigator
Melanie Thamm, MD, Sub-Investigator

Department of Pulmology; Hannover Medical School, Hannover, Germany; Recruiting
Marius M Hoeper
Marius M Hoeper, MD, PhD, Principal Investigator
Karen Olsson, MD, Sub-Investigator

German Heart Centre, Munich, Germany; Recruiting
Harald Kaemmerer, MD,. PhD
Harald Kaemmerer, MD, PhD, Principal Investigator

Mater Misericordiae, Dublin, Ireland; Recruiting
Sean Gaine, MD, PhD
Sean Gaine, MD, PhD, Principal Investigator

Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy; Recruiting
Dario Vizza, MD, PhD
Dario Vizza, MD, PhD, Principal Investigator

Dept. for Rheumatology, University Hospital, Zurich, Switzerland; Recruiting
Oliver Distler, MD, PhD
Oliver Distler, MD, PhD, Principal Investigator

Additional Information

Related publications:

Pittrow D, Ghofrani HA, Opitz CF, Huscher D, Hoeper MM. [International, prospective register for the documentation of first-line and maintenance therapy in patients with pulmonary hypertension (CompERA-XL)]. Dtsch Med Wochenschr. 2009 Aug;134 Suppl 5:S173-5. doi: 10.1055/s-0029-1225318. Epub 2009 Aug 28. Review. German.

Starting date: June 2007
Last updated: July 16, 2014

Page last updated: August 23, 2015

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