Eisenmenger Quality Enhancement Research Initiative
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Other: Subjects with diagnosis of Eisenmenger Syndrome
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 193
- 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
- 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
- Arm && Interventions
Group Intervention Description diagnosis of Eisenmenger Syndrome Subjects with diagnosis of Eisenmenger Syndrome subjects with diagnosis of Eisenmenger Syndrome
- 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)
Trial Locations
- Locations (51)
Fletcher Allen Health Care
🇺🇸Burlington, Vermont, United States
The Pennsylvania State University College of Medicine and The Pennsylvania State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
University of Southern California Adult Congenital Heart Disease Care Program
🇺🇸Los Angeles, California, United States
University of Maryland School of Medicine
🇺🇸Baltimore, Maryland, United States
The Cleveland Clinic Adult Congenital Heart Disease Center
🇺🇸Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
The Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Temple University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Texas Children's Hospital/Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Children's Heart Center Nevada
🇺🇸Las Vegas, Nevada, United States
UC Health/University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
CINCINNATI Children's Hospital Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Minnesota Physicians Heart Fairview
🇺🇸Minneapolis, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Lucile Packard Children's Hospital
🇺🇸Palo Alto, California, United States
East Carolina University
🇺🇸Greenville, North Carolina, United States
Ahmanson / UCLA Adult Congenital Heart Disease Center
🇺🇸Los Angeles, California, United States
Lenox Hill Hospital
🇺🇸New York, New York, United States
Berkeley Cardiovascular Medical Group
🇺🇸Oakland, California, United States
Children's National Medical Center and Washington Hospital Center
🇺🇸Washington, District of Columbia, United States
Cohen's Children's Medical Center of New York - Adult Congenital Heart Disease Program
🇺🇸New Hyde Park, New York, United States
The Cardiovascular Group Centra
🇺🇸Lynchburg, Virginia, United States
Pediatric Cardiology Associates
🇺🇸Portland, Maine, United States
Columbia University Pulmonary Hypertension Center
🇺🇸New York, New York, United States
Methodist Lebonheur Healthcare, UT Lebonheur Pediatric Specialists
🇺🇸Memphis, Tennessee, United States
University of Virginia Health Systems
🇺🇸Charlottesville, Virginia, United States
Bassett Healthcare Network - Bassett Medical Center
🇺🇸Cooperstown, New York, United States
Harbor - UCLA Medical Center - Adult Congenital Heart Disease Program - Division of Cardiology
🇺🇸Torrance, California, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, North Carolina, United States
The University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Asheville Cardiology Associates
🇺🇸Asheville, North Carolina, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
The University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Providence Sacred Heart Medical Center and Children's Hospital
🇺🇸Spokane, Washington, United States
Barnes-Jewish Hospital/St. Louis Children's Hospital / Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Children's Specialty Group PLLC, Children's Hospital of the King's Daughters
🇺🇸Norfolk, Virginia, United States
Children's Hospital Boston and Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Centre for Adult Congenital Heart Disease at California Pacific
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Yale School of Medicine - Adult Congenital Heart Disease Program
🇺🇸New Haven, Connecticut, United States
University of Louisville, Pediatric Cardiology
🇺🇸Louisville, Kentucky, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Children's Hospital of Wisconsin, Medical College of Wisconsin Adult Congenital Heart Disease Program
🇺🇸Milwaukee, Wisconsin, United States
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Mid-America Heart Institute / Saint Luke's Hospital / Saint Luke's Cardiovascular Consultants
🇺🇸Kansas City, Missouri, United States
Oregon Health and Sciences University
🇺🇸Portland, Oregon, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Montefiore Medical Center - Moses Division;The University Hospital for Albert Einstein College of Medicine
🇺🇸Bronx, New York, United States