Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Other: Subjects with diagnosis of Eisenmenger Syndrome

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 Type: Observational
• Enrollment (Actual): 193

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • The University of Arkansas for Medical Sciences
  • California
    • Los Angeles, California, United States, 90033
      • University of Southern California Adult Congenital Heart Disease Care Program
    • Los Angeles, California, United States, 90095
      • Ahmanson / UCLA Adult Congenital Heart Disease Center
    • Oakland, California, United States, 94609
      • Berkeley Cardiovascular Medical Group
    • Palo Alto, California, United States, 94303
      • Lucile Packard Children's Hospital
    • San Francisco, California, United States, 94115
      • Centre for Adult Congenital Heart Disease at California Pacific
    • San Francisco, California, United States, 94143-0214
      • University of California, San Francisco
    • Torrance, California, United States, 90502
      • Harbor - UCLA Medical Center - Adult Congenital Heart Disease Program - Division of Cardiology
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale School of Medicine - Adult Congenital Heart Disease Program
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center and Washington Hospital Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
    • Chicago, Illinois, United States, 60637
      • University of Chicago
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • The University of Kansas Hospital
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, Pediatric Cardiology
  • Maine
    • Portland, Maine, United States, 04102
      • Pediatric Cardiology Associates
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland School of Medicine
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston and Brigham and Women's Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota Physicians Heart Fairview
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Mid-America Heart Institute / Saint Luke's Hospital / Saint Luke's Cardiovascular Consultants
    • Saint Louis, Missouri, United States, 63110
      • Barnes-Jewish Hospital/St. Louis Children's Hospital / Washington University School of Medicine
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Children's Heart Center Nevada
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center - Moses Division;The University Hospital for Albert Einstein College of Medicine
    • Cooperstown, New York, United States, 13326
      • Bassett Healthcare Network - Bassett Medical Center
    • New Hyde Park, New York, United States, 11040
      • Cohen's Children's Medical Center of New York - Adult Congenital Heart Disease Program
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
    • New York, New York, United States, 10032
      • Columbia University Pulmonary Hypertension Center
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Asheville Cardiology Associates
    • Charleston, North Carolina, United States, 29425
      • Medical University of South Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center
    • Cincinnati, Ohio, United States, 45219
      • UC Health/University of Cincinnati
    • Cleveland, Ohio, United States, 44195
      • The Cleveland Clinic Adult Congenital Heart Disease Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center
    • Columbus, Ohio, United States, 43215
      • The Research Institute at Nationwide Children's Hospital
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Sciences University
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • The Pennsylvania State University College of Medicine and The Pennsylvania State Milton S. Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • Methodist Lebonheur Healthcare, UT Lebonheur Pediatric Specialists
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Houston, Texas, United States, 77005
      • Texas Children's Hospital/Baylor College of Medicine
  • Vermont
    • Burlington, Vermont, United States, 05401
      • Fletcher Allen Health Care
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health Systems
    • Lynchburg, Virginia, United States, 24501
      • The Cardiovascular Group Centra
    • Norfolk, Virginia, United States, 23507
      • Children's Specialty Group PLLC, Children's Hospital of the King's Daughters
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center and Children's Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Children's Hospital of Wisconsin, Medical College of Wisconsin Adult Congenital Heart Disease Program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

diagnosis of Eisenmenger Syndrome; subjects with diagnosis of Eisenmenger Syndrome

Other: Subjects with diagnosis of Eisenmenger Syndrome; Antibiotic recommendation for SBE prophylaxis and influenza vaccine; Contraception counseling, and recommendations regarding avoidance of pregnancy; Documentation and prescription of the specific medications:OxygenDiureticASA, AnticoagulantCCB, BB, ACEI, ARBIron SupplementationAllopurinolPAH specific therapy; Other Names: management of Eisenmenger Syndrome

What is the study measuring?

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	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)

Collaborators and Investigators

• Sponsor: Actelion
• Collaborators: Canadian Heart Research Centre
• Investigators: Study Chair: Michael Landzberg, MD, Harvard Medical School / Boston Adult Congenital Heart; Study Director: Gary Palmer, MD, MBA, Actelion Pharmaceuticals U.S., Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): April 17, 2018
• Study Completion (Actual): April 17, 2018

Study Registration Dates

• First Submitted: May 9, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (Estimate): June 20, 2012

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Eisenmenger
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Congenital Abnormalities; Hypertension, Pulmonary; Heart Defects, Congenital; Cardiovascular Abnormalities; Hypertension; Pulmonary Arterial Hypertension; Eisenmenger Complex
• Other Study ID Numbers: AC-052-435