Adult Congenital Heart Disease Registry (QuERI)
Multi-center, observational, U.S.-based longitudinal program. Data will be collected prospectively for 3 years. Individual physician feedback will be provided on data collected with the purpose of improving the management of patients - quality enhancement research initiative (QuERI) process from adult patients enrolled with a history of repaired Congenital Heart Disease (CHD).
Pulmonary Arterial Hypertension
Congenital Heart Disease
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Adult Congenital Heart Disease Quality Enhancement Research Initiative|
- To characterize the clinical course in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]outcome measure: clinical outcomes: Assessment of function status, medications, and laboratory results, as well as an evaluation of medical history, physical examination, ECG, and echocardiography, in adult congenital heart disease patients at risk for pulmonary hypertension.
- To characterize the clinical outcomes in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]outcome measure: clinical rate: To assess the rate of newly diagnosed pulmonary arterial hypertension in a cohort of adults with repaired congenital heart disease at risk for pulmonary arterial hypertension. To also compare clinical outcomes in patients who do and do not meet prespecified echocardiography criteria for suspected pulmonary arterial hypertension.
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Adult CHD Patients
yearly clinical visits
Other Name: observational
Approximately 800 male and female adult patients with a history of repaired CHD will be recruited from approximately 100 cardiology practices and will be followed up every twelve months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Two groups of subjects will be enrolled based on identical exclusion criteria and inclusion criteria, with the exception only of inclusion criteria #3: cohort 1- those demonstrating historic high risk criteria and cohort 2 - those demonstrating current high risk criteria.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01659411
|Contact: Anatoly Langer, MDfirstname.lastname@example.org|
Show 59 Study Locations
|Study Director:||Alain Romero, PharmD||Actelion Pharmaceuticals U.S., Inc.|
|Study Chair:||Michael Landzberg, MD||Harvard Medical School / Boston Adult Congenital Heart|