Clinical trial NCT01347216: COMPERA / COMPERA-KIDS
Official title: Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Arterial Hypertension (PAH)
Pulmonary Hypertension (PH)
Keywords: Drug treatment
Treatment pathways
Clinical routine
Registry
Treatment outcomes
Endothelin receptor antagonist
Phosphodiesterase-V inhibitor
Prostanoid
Sildenafil
Bosentan
Macitentan
Sitaxentan
Ambrisentan
Imatinib
Epoprostenol
Treprostinil
Iloprost
Infusion pump
Riociguat
soluble guanylate cyclase stimulator
Quality of life
Patient-related outcomes
Economic model
Adverse event
Safety
Combination therapy
Internet
Europe
Eisenmenger
Adults
Children
Selexipag
Baltic states
Risk
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
Collaborators: name: GWT-TUD GmbH
First posted: 2011-05-04
Enrollment: 13000
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any manifestation of pulmonary hypertension

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).

Detailed description: 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").

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).

Primary outcomes:
measure: Number of patients on monotherapy vs combination therapies at baseline and during follow-up (drug utilisation patterns)
timeFrame: Up to 10 years after inclusion
Secondary outcomes:
measure: Number of patients in the various Dana Point groups (patient characteristics in PAH and non-PAH pulmonary hypertension groups)
timeFrame: Up to 10 years after inclusion
measure: Probability of survival in the various Dana Point groups (PAH and non-PAH pulmonary hypertension groups) by Kaplan-Meier estimate
timeFrame: Up to 10 years after inclusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Dept. of Pneumology, University
city: Berlin
country: Germany
facility: DRK-Klinikum Köpenick
city: Giessen
country: Germany
facility: Lung Centre, University of Giessen
city: Hannover
country: Germany
facility: Department of Pulmology; Hannover Medical School
city: Munich
country: Germany
facility: German Heart Centre
city: Rome
country: Italy
facility: Department of Cardiovascular and Respiratory Sciences, University La Sapienza
city: Zurich
country: Switzerland
facility: Dept. for Rheumatology, University Hospital
Study officials:
affiliation: Department of Pulmonology, Medical School Hannover, Germany
name: Marius M Hoeper, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lung Centre, Giessen, Germany
name: Ardeschir H. Ghofrani, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept of Pneumology, University Leuven, Belgium
name: Marion Delcroix, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Cardiovascular and Respiratory Sciences, University La Sapienza, Rome, Italy
name: Dario Vizza, MD, PhD
role: STUDY_DIRECTOR
affiliation: Institute for Clinical Pharmacoloy, Medical Faculty, Technical University Dresden, Germany
name: David Pittrow, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department of Cardiology, DRK-Kliniken Berlin, Germany
name: Christian Opitz, MD, PhD
role: STUDY_DIRECTOR
affiliation: Department for Rheumatology, University Hospital Zurich, Switzerland
name: Oliver Distler, MD, PhD
role: STUDY_DIRECTOR
affiliation: German Heart Centre, Munich, Germany
name: Harald Kaemmerer, MD, PhD
role: STUDY_DIRECTOR
affiliation: Heart Centre, Cologne
name: Stephan Rosenkranz, MD, PhD
role: STUDY_DIRECTOR
affiliation: Centre for Pulmonary Hypertension at Thoraxclinic Heidelberg, Germany
name: Ekkehard Grünig, MD, PhD
role: STUDY_DIRECTOR
affiliation: Dept. Paed. Cardiol./Congenital Cardiology, Heidelberg University Medical Centre, Germany
name: Matthias Gorenflo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Pulmonology, Medical School Hannove
name: Karen Olsson, MD, PhD
role: STUDY_DIRECTOR
References:
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