Eisenmenger Quality Enhancement Research Initiative

Completed

• Conditions: Pulmonary Arterial Hypertension

• Registration Number: NCT01623492
• Lead Sponsor: Actelion

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.

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.

Study Timeline

• Study First Submitted: 2012-05-09
• Study First Submitted QC: 2012-06-19
• Study First Posted: 2012-06-20
• Study Start: 2012-07-01
• Primary Completion: 2018-04-17
• Study Completion: 2018-04-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 193

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Characterization of the clinical course of patients with Eisenmenger Syndrome	up to 3 years	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.

Secondary Outcome Measures

Name	Time	Method
Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications.	baseline (visit 1) thru end of study (3 years)
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)