Clinical Trials

COMPERA / COMPERA-KIDS

Study 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. Since July 2013, also children of any age can be documented (COMPERA-KIDS).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Week and Over
Gender	All

More Inclusion & Exclusion 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 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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT01347216
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Technische Universität Dresden
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Marius M Hoeper, MD, PhDArdeschir H. Ghofrani, MD, PhDMarion Delcroix, MD, PhDDario Vizza, MD, PhDDavid Pittrow, MD, PhDChristian Opitz, MD, PhDOliver Distler, MD, PhDHarald Kaemmerer, MD, PhDStephan Rosenkranz, MD, PhDEkkehard Grünig, MD, PhDMatthias Gorenflo, MD, PhDKaren Olsson, MD, PhD
Principal Investigator Affiliation	Department of Pulmonology, Medical School Hannover, GermanyLung Centre, Giessen, GermanyDept of Pneumology, University Leuven, BelgiumDepartment of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, ItalyInstitute for Clinical Pharmacoloy, Medical Faculty, Technical University Dresden, GermanyDepartment of Cardiology, DRK-Kliniken Berlin, GermanyDepartment for Rheumatology, University Hospital Zurich, SwitzerlandGerman Heart Centre, Munich, GermanyHeart Centre, CologneCentre for Pulmonary Hypertension at Thoraxclinic Heidelberg, GermanyDept. Paed. Cardiol./Congenital Cardiology, Heidelberg University Medical Centre, GermanyDepartment of Pulmonology, Medical School Hannove
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Belgium, Germany, Italy, Switzerland
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH)
Study Website:	View Trial Website

Additional Details

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").

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.