COMPERA / COMPERA-KIDS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1+
SponsorTechnische Universität Dresden
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All age groups (amendment dated 1 June 2013)
Written informed consent
Pulmonary hypertension (PH) of either
PAH: idiopathic form (IPAH) or
Disqualifiers
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 population
Patients with any manifestation of pulmonary hypertension
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns)
Time frame
Up to 10 years after inclusionSecondary outcomes
1
Number of patients in the various Dana Point groups (patient characteristics in PAH and non-PAH pulmonary hypertension groups)
Time frame
Up to 10 years after inclusion2
Probability of survival in the various Dana Point groups (PAH and non-PAH pulmonary hypertension groups) by Kaplan-Meier estimate
Time frame
Up to 10 years after inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Technische Universität Dresden
Lead sponsor
GWT-TUD GmbH
Collaborator
Source ClinicalTrials.gov