| NCT ID | NCT01347216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Technische Universität Dresden |
| Condition | Pulmonary Arterial Hypertension (PAH) |
| Study Type | OBSERVATIONAL |
| Enrollment | 14,000 participants |
| Start Date | 2007-07-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 14,000 participants in total. It began in 2007-07-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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).
Contact & Investigator
Marius M Hoeper, MD, PhD
PRINCIPAL INVESTIGATOR
Department of Pulmonology, Medical School Hannover, Germany
Frequently Asked Questions
Who can join the NCT01347216 clinical trial?
This trial is open to participants of all sexes, aged 1 Week or older, studying Pulmonary Arterial Hypertension (PAH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01347216 currently recruiting?
Yes, NCT01347216 is actively recruiting participants. Contact the research team at david.pittrow@mailbox.tu-dresden.de for enrollment information.
Where is the NCT01347216 trial being conducted?
This trial is being conducted at Leuven, Belgium, Berlin, Germany, Giessen, Germany, Hanover, Germany and 3 additional locations.
Who is sponsoring the NCT01347216 clinical trial?
NCT01347216 is sponsored by Technische Universität Dresden. The principal investigator is Marius M Hoeper, MD, PhD at Department of Pulmonology, Medical School Hannover, Germany. The trial plans to enroll 14,000 participants.