Actively Recruiting

Age: 1Week +
All Genders
NCT01347216

COMPERA / COMPERA-KIDS

Led by Technische Universität Dresden · Updated on 2025-08-24

14000

Participants Needed

7

Research Sites

1017 weeks

Total Duration

On this page

Sponsors

T

Technische Universität Dresden

Lead Sponsor

G

GWT-TUD GmbH

Collaborating Sponsor

AI-Summary

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).

CONDITIONS

Official Title

COMPERA / COMPERA-KIDS

Who Can Participate

Age: 1Week +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • All age groups are eligible
  • Written informed consent is required
  • Diagnosis of pulmonary hypertension (PH) including idiopathic PAH, PAH associated with connective tissue diseases, congenital heart defects, HIV infection, or portopulmonary form
  • Chronic thromboembolic PH (CTEPH) patients
  • PH related to left heart diseases or pulmonary diseases
  • "Relative PH" after specific heart surgeries such as cavopulmonary anastomosis or Fontan-type surgery
  • Newly initiated therapy with ERA, PDE-5 inhibitors, sGC stimulators, or prostacyclins within 3 months before first documentation
  • PAH-CHD patients on maintenance therapy or with severe pulmonary vascular disease such as Eisenmenger physiology are also eligible
Not Eligible

You will not qualify if you...

  • Patients on maintenance therapy with any ERA, PDE-5 inhibitor, prostacyclin, or sGC stimulator longer than 3 months before first documentation (except PAH-CHD patients)

AI-Screening

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Trial Site Locations

Total: 7 locations

1

Dept. of Pneumology, University

Leuven, Belgium

Actively Recruiting

2

DRK-Klinikum Köpenick

Berlin, Germany

Actively Recruiting

3

Lung Centre, University of Giessen

Giessen, Germany

Actively Recruiting

4

Department of Pulmology; Hannover Medical School

Hanover, Germany

Actively Recruiting

5

German Heart Centre

Munich, Germany

Actively Recruiting

6

Department of Cardiovascular and Respiratory Sciences, University La Sapienza

Rome, Italy

Actively Recruiting

7

Dept. for Rheumatology, University Hospital

Zurich, Switzerland

Actively Recruiting

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Research Team

D

David Pittrow, MD, PhD

CONTACT

M

Marius M. Hoeper, MD, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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