Recruiting

COMPERA / COMPERA-KIDS

ClinicalTrials.gov IDNCT01347216

PhaseNot Applicable

Enrollment14000

SponsorTechnische Universität Dresden

Age1 Week and older

SexALL

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Conditions studied

Pulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH)

About this study

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).

Primary outcomes

Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns) (Up to 10 years after inclusion)

Eligibility information

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).

Study locations

Dept. of Pneumology, University, Leuven, Belgium
DRK-Klinikum Köpenick, Berlin, Germany
Lung Centre, University of Giessen, Giessen, Germany
Department of Pulmology; Hannover Medical School, Hanover, Germany
German Heart Centre, Munich, Germany
Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy
Dept. for Rheumatology, University Hospital, Zurich, Switzerland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-16.