Ignite Creation Date:
2024-05-05 @ 11:29 PM
Last Modification Date:
2024-10-26 @ 10:35 AM
Study NCT ID:
NCT01347216
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2011-05-03
Brief Title:
COMPERA COMPERA-KIDS
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COMPERA
Brief Summary:
In view of the manifold options for mono- and combination therapy that have now emerged for patients with pulmonary arterial hypertension PHPAH controlled clinical trials can only provide part of the information needed for optimal management In order to gather adequate data on PAHPH treatment in routine clinical care the ongoing COMPERA registry prospectively documents consecutive patients with newly initiated treatment of PAHPAH 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None