Brief Summary
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.
Brief Title
Eisenmenger Quality Enhancement Research Initiative
Detailed Description
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Pulmonary Arterial Hypertension
Eligibility Criteria
Inclusion Criteria:
* Male and female patients
* Diagnosis of Eisenmenger syndrome based on right heart catheterization data
* Right to Left intra-cardiac shunting
* PAH
* Need for comprehensive management according to guidelines and peer-reviewed evidence
* Ability and desire to execute the consent for follow up
Exclusion Criteria:
* Poor mental function, drug, or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
* Prior inclusion in this program
* Male and female patients
* Diagnosis of Eisenmenger syndrome based on right heart catheterization data
* Right to Left intra-cardiac shunting
* PAH
* Need for comprehensive management according to guidelines and peer-reviewed evidence
* Ability and desire to execute the consent for follow up
Exclusion Criteria:
* Poor mental function, drug, or substance (e.g.,alcohol) abuse, or unstable psychiatric illness, which, in the opinion of the investigator, may interfere with optimal participation in the study
* Prior inclusion in this program
Inclusion Criteria
Inclusion Criteria:
* Male and female patients
* Diagnosis of Eisenmenger syndrome based on right heart catheterization data
* Right to Left intra-cardiac shunting
* PAH
* Need for comprehensive management according to guidelines and peer-reviewed evidence
* Ability and desire to execute the consent for follow up
* Male and female patients
* Diagnosis of Eisenmenger syndrome based on right heart catheterization data
* Right to Left intra-cardiac shunting
* PAH
* Need for comprehensive management according to guidelines and peer-reviewed evidence
* Ability and desire to execute the consent for follow up
Gender
All
Gender Based
false
Keywords
Eisenmenger
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT01623492
Org Class
Industry
Org Full Name
Actelion
Org Study Id
AC-052-435
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Eisenmenger Quality Enhancement Research Initiative
Primary Outcomes
Outcome Description
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.
Outcome Measure
Characterization of the clinical course of patients with Eisenmenger Syndrome
Outcome Time Frame
up to 3 years
Secondary Outcomes
Outcome Time Frame
baseline (visit 1) thru end of study (3 years)
Outcome Measure
Characterization of the demographics of patients with Eisenmenger Syndrome
Outcome Time Frame
baseline (visit 1) thru end of study (3 years)
Outcome Measure
Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome.
Outcome Time Frame
baseline (visit 1) thru end of study (3 years)
Outcome Measure
Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Ali Zaidi
Investigator Email
azaidi@montefiore.org
Investigator Phone