Actively Recruiting

Age: 1Week +
All Genders
ID01347216

Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA and COMPERA-KIDS)

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

14000

Participants Needed

7

Research Sites

N/A

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

Researchers are collecting detailed information on patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) who are starting new treatments. The study aims to understand patient characteristics, treatment patterns, clinical outcomes including survival, and how current treatment guidelines are being applied. It includes both adults and children of any age and captures data on different PH forms, including cases linked to congenital heart disease or other conditions. The registry tracks patients receiving newly initiated therapies such as endothelin receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators, or prostacyclins, either alone or in combination. Special groups such as patients with PAH associated with congenital heart disease or Eisenmenger physiology are also included. The data collection is ongoing, with follow-up for up to 10 years after enrollment. Participants are documented through an internet-based registry that maintains high data quality using automated checks and monitoring. Researchers evaluate treatment patterns, patient survival, and clinical predictors over time. This observational study does not involve experimental treatments but collects real-world data from routine clinical care to help optimize PAH and PH management. Participation duration varies with follow-up extending up to 10 years after inclusion.

CONDITIONS

Brief 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 linked to connective tissue diseases, congenital heart defects, HIV infection, portopulmonary form, chronic thromboembolic PH, PH due to left heart diseases, pulmonary diseases, or relative PH after specific heart surgeries
  • Newly started therapy within 3 months for PAH/PH with endothelin receptor antagonists, phosphodiesterase-5 inhibitors, soluble guanylate cyclase stimulators, or prostacyclins in mono- or combination therapy
  • PAH-CHD patients on maintenance or newly started therapy are eligible without the 3-month limit
  • PAH-CHD patients with severe pulmonary vascular disease including Eisenmenger physiology are eligible regardless of treatment
Not Eligible

You will not qualify if you...

  • Patients on maintenance therapy longer than 3 months before first documentation are excluded, except PAH-CHD patients

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 10 years after inclusion

Participants are observed over time to collect data on treatment patterns, clinical course, and outcomes related to pulmonary hypertension.

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

M

Marius M. Hoeper, MD, PhD

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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Published Research Related To This Trial

[International, prospective register for the documentation of first-line and maintenance therapy in patients with pulmonary hypertension (CompERA-XL)].

D Pittrow, H A Ghofrani, C F Opitz...

https://pubmed.ncbi.nlm.nih.gov/19718609

Performance of the ESC/ERS 4-strata risk stratification model for pulmonary arterial hypertension with missing variables.

Christine Pausch, David Pittrow, Marius M Hoeper...

https://pubmed.ncbi.nlm.nih.gov/37802633

Elderly patients diagnosed with idiopathic pulmonary arterial hypertension: results from the COMPERA registry.

Marius M Hoeper, Doerte Huscher, H Ardeschir Ghofrani...

https://pubmed.ncbi.nlm.nih.gov/23164592

Anticoagulation and survival in pulmonary arterial hypertension: results from the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA).

Karen M Olsson, Marion Delcroix, H Ardeschir Ghofrani...

https://pubmed.ncbi.nlm.nih.gov/24081973

Mortality in pulmonary arterial hypertension: prediction by the 2015 European pulmonary hypertension guidelines risk stratification model.

Marius M Hoeper, Tilmann Kramer, Zixuan Pan...

https://pubmed.ncbi.nlm.nih.gov/28775047

The 6MWT as a prognostic tool in pulmonary arterial hypertension: results from the COMPERA registry.

Thomas A Zelniker, Dörte Huscher, Anton Vonk-Noordegraaf...

https://pubmed.ncbi.nlm.nih.gov/29368137

Pulmonary Hypertension in Adults with Congenital Heart Disease: Real-World Data from the International COMPERA-CHD Registry.

Harald Kaemmerer, Matthias Gorenflo, Dörte Huscher...

https://pubmed.ncbi.nlm.nih.gov/32414075