COMPERA / COMPERA-KIDS
Recruiting · NCT01347216 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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).
Who can take part
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).
Where it is running
7 locations listed.
- DRK-Klinikum Köpenick - Berlin, Germany
- Lung Centre, University of Giessen - Giessen, Germany
- Department of Pulmology; Hannover Medical School - Hanover, Germany
- Dept. of Pneumology, University - Leuven, Belgium
- German Heart Centre - Munich, Germany
- Department of Cardiovascular and Respiratory Sciences, University La Sapienza - Rome, Italy
- Dept. for Rheumatology, University Hospital - Zurich, Switzerland