NCT01347216Recruiting
COMPERA / COMPERA-KIDS
Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension
Source: ClinicalTrials.gov · Last updated 24 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 14000 (estimated)
- First submitted
- 3 May 2011
- Start date
- 1 Jul 2007
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Technische Universität Dresden
- NCT number
- NCT01347216
What you commit to
- Study type: Observational
- Planned participants: 14000
- From 1 Jul 2007 to the primary completion date, 31 Dec 2026
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Who the study is looking for
- 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.
Age in the registry: 1 week to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Pneumology, University Coordinator of this site? Confirm its status | Leuven | Belgium | Recruiting |
| Dept. for Rheumatology, University Hospital Coordinator of this site? Confirm its status | Zurich | Switzerland | Recruiting |
| DRK-Klinikum Köpenick Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Lung Centre, University of Giessen Coordinator of this site? Confirm its status | Giessen | Germany | Recruiting |
| Department of Pulmology; Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Recruiting |
| German Heart Centre Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Department of Cardiovascular and Respiratory Sciences, University La Sapienza Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.