Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)
Eisenmenger Quality Enhancement Research Initiative (QuERI) is a multi-center, observational, US-based longitudinal program, with enrollment of consecutive Eisenmenger patients who meet enrollment. Patient data will be collected prospectively for three 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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Eisenmenger Quality Enhancement Research Initiative|
- Characterization of the clinical course of patients with Eisenmenger Syndrome [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]The management of Eisenmenger Syndrome patients over the three year registry period will be compared with established national guidelines. In addition, The Minnesota Living with Heart Failure questionnaire (MLHFQ) will be collected.
- Characterization of the demographics of patients with Eisenmenger Syndrome [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]
- Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome. [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]
- Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications. [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood samples will be collected at Baseline and at each of the annual visits. In addition, urine sampling will be performed at Baseline. An analysis of biomarkers will be performed at a hospital core laboratory.
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
diagnosis of Eisenmenger Syndrome
subjects with diagnosis of Eisenmenger Syndrome
Other: subjects with diagnosis of Eisenmenger Syndrome
Other Name: management of Eisenmenger Syndrome
Approximately 200 male and female adult patients with a history of Eisenmenger will be recruited from approximately 50 cardiology practices over a period of 18 months and will be followed up every six months for the period of three years. Consecutive patients in each practice meeting inclusion and exclusion criteria should be considered for the study. Participating sites will be asked to maintain a screening log to identify which inclusion or exclusion criteria was not met thus excluding them from the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01623492
|Contact: Anatoly Langer, MDfirstname.lastname@example.org|
Show 51 Study Locations
|Study Director:||Alain Romero, PharmD||Actelion Pharmaceuticals U.S., Inc.|
|Study Chair:||Michael Landzberg, MD||Harvard Medical School / Boston Adult Congenital Heart|