Registry for patients with pulmonary hypertension and their treatment outcomes
Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension
This study is collecting information from patients with pulmonary hypertension who have just started treatment to see how well different therapies are working in real-life settings.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 14000 (estimated) |
| Ages | 1 Week and up |
| Sex | All |
| Sponsor | Technische Universität Dresden Academic / other |
| Locations | 7 sites (Leuven and 6 other locations) |
| Trial ID | NCT01347216 on ClinicalTrials.gov |
What this trial studies
The COMPERA registry collects data on patients with pulmonary arterial hypertension (PAH) and pulmonary hypertension (PH) who have recently started treatment. It aims to document patient demographics, clinical outcomes, and the effectiveness of various treatment strategies in routine clinical practice. The registry employs high-quality standards, including automated data checks and monitoring, to ensure reliable information. It also allows participating centers to compare their results with others, contributing to quality assurance and identifying evolving research needs in the PAH community.
Who should consider this trial
Good fit: Ideal candidates include patients of all ages who have recently initiated therapy for various forms of pulmonary hypertension.
Not a fit: Patients who have not started treatment for pulmonary hypertension or those with forms of the disease not covered by the registry may not benefit.
Why it matters
Potential benefit: If successful, this registry could improve treatment strategies and outcomes for patients with pulmonary hypertension.
How similar studies have performed: Other registries and observational studies have shown success in improving treatment outcomes for patients with pulmonary hypertension, indicating that this approach is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Leuven and 6 other locations
- Dept. of Pneumology, University — Leuven, Belgium (Recruiting)
- DRK-Klinikum Köpenick — Berlin, Germany (Recruiting)
- Lung Centre, University of Giessen — Giessen, Germany (Recruiting)
- Department of Pulmology; Hannover Medical School — Hanover, Germany (Recruiting)
- German Heart Centre — Munich, Germany (Recruiting)
- Department of Cardiovascular and Respiratory Sciences, University La Sapienza — Rome, Italy (Recruiting)
- Dept. for Rheumatology, University Hospital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marius M Hoeper, MD, PhD — Department of Pulmonology, Medical School Hannover, Germany
- Study coordinator: David Pittrow, MD, PhD
- Email: david.pittrow@mailbox.tu-dresden.de
- Phone: +498152
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.