NCT01623492

Eisenmenger Quality Enhancement Research Initiative

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 193 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
OTHER	Subjects with diagnosis of Eisenmenger Syndrome	1. Antibiotic recommendation for SBE prophylaxis and influenza vaccine 2. Contraception counseling, and recommendations regarding avoidance of pregnancy 3. Documentation and prescription of the specific medications: 1. Oxygen 2. Diuretic 3. ASA, Anticoagulant 4. CCB, BB, ACEI, ARB 5. Iron Supplementation 6. Allopurinol 7. PAH specific therapy

Timeline

• Start date: 2012-07-01
• Primary completion: 2018-04-17
• Completion: 2018-04-17
• First posted: 2012-06-20
• Last updated: 2025-02-03