COMPERA / COMPERA-KIDS — COMPERA  

Pulmonary Arterial Hypertension (PAH) Clinical Trial

Official title: Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension

Status Recruiting

Clinical Trial 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).

Clinical Trial 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"). ;

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Arterial Hypertension (PAH)
• Pulmonary Hypertension (PH)

• NCT number: NCT01347216
• Study type: Observational
• Source: Technische Universität Dresden
• Contact: David Pittrow, MD, PhD
• Phone: +498152
• Email: david.pittrow@mailbox.tu-dresden.de
• Status: Recruiting
• Start date: July 1, 2007
• Completion date: June 1, 2026