Eisenmenger Quality Enhancement Research Initiative

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Eisenmenger Quality Enhancement Research Initiative

Conditions
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Pulmonary Arterial Hypertension

Intervention / Treatment
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* Other: Subjects with diagnosis of Eisenmenger Syndrome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diagnosis of Eisenmenger Syndrome<br>subjects with diagnosis of Eisenmenger Syndrome | Other: Subjects with diagnosis of Eisenmenger Syndrome<br>* Antibiotic recommendation for SBE prophylaxis and influenza vaccine Contraception counseling, and recommendations regarding avoidance of pregnancy Documentation and prescription of the specific medications: Oxygen Diuretic ASA, Anticoagulant CCB, BB, ACEI, ARB Iron Supplementation Allopurinol PAH specific therapy<br>* Other names: management of Eisenmenger Syndrome;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the clinical course of patients with Eisenmenger Syndrome | 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. | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterization of the demographics of patients with Eisenmenger Syndrome |  | baseline (visit 1) thru end of study (3 years) | 
| Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome. |  | baseline (visit 1) thru end of study (3 years) | 
| Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications. |  | baseline (visit 1) thru end of study (3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eisenmenger