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COMPERA / COMPERA-KIDS | Clinical Trials | Clareo Health

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RECRUITINGNCT01347216

COMPERA / COMPERA-KIDS

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 o...

Lead sponsor: Technische Universität Dresden•7 locations•View source on ClinicalTrials.gov

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Contacts

David Pittrow, MD, PhD

CONTACT

+498152 david.pittrow@mailbox.tu-dresden.de

Marius M. Hoeper, MD, PhD

CONTACT

+49511532 Hoeper.Marius@mh-hannover.de

Sponsors

Lead Sponsor

Technische Universität Dresden

Collaborators

GWT-TUD GmbH

COMPERA will report current and comprehensive data on * Demographics and clinical course of incident and prevalent PAH and PH patients * Patient outcomes including survival, by subgroup, by treatment strategy and other factors * Clinical predictors of short-term and long-term clinical outcomes * Relationship between PAH medications and patient outcomes * Temporal trends in treatments and outcomes for newly diagnosed patients * The state of implementation of current PAH guidelines * Evolving research needs of the PAH community * Patients with PAH associated with congenital heart disease and Eisenmenger physiology who do not receive specific drug therapy for PAH ("COMPERA-Eisenmenger", as stated in the amendment dated 23. January 2012). * Children of any age with PH or PAH (all Dana Point groups), as stated in the amendment dated 1 June 2013 ("COMPERA-KIDS").

Age

0 - No limit years

Sex

ALL

Healthy Volunteers

No

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).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 24, 2025Terms

Trial snapshot

StatusRECRUITING

Phase—

Enrollment14,000

Start dateJul 2007

Last updatedAug 24, 2025

Condition

Pulmonary Arterial Hypertension (PAH)Pulmonary Hypertension (PH)

Locations shown

Dept. of Pneumology, University

Leuven

DRK-Klinikum Köpenick

Berlin

Lung Centre, University of Giessen

Giessen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 24, 2025Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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