Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01623492
First received: May 9, 2012
Last updated: March 1, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention
Pulmonary Arterial Hypertension
Other: Subjects with diagnosis of Eisenmenger Syndrome

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Eisenmenger Quality Enhancement Research Initiative

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Characterization of the clinical course of patients with Eisenmenger Syndrome [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Characterization of the demographics of patients with Eisenmenger Syndrome [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]
  • Identification of clinical predictors of short-term and long-term outcomes of patients with Eisenmenger Syndrome. [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]
  • Characterization of patients treated with PAH-specific medications to patients untreated with PAH-specific medications. [ Time Frame: baseline (visit 1) thru end of study (3 years) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA
Blood samples will be collected at Baseline and at each of the annual visits. In addition, urine sampling will be performed at Baseline. An analysis of biomarkers will be performed at a hospital core laboratory.

Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
diagnosis of Eisenmenger Syndrome
subjects with diagnosis of Eisenmenger Syndrome
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
Other Name: management 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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
200 adult patients with Eisenmenger Syndrome recruited from approximately 50 US cardiology practices.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623492

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

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01623492     History of Changes
Other Study ID Numbers: AC-052-435 
Study First Received: May 9, 2012
Last Updated: March 1, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Actelion:
Eisenmenger

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Eisenmenger Complex
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Heart Defects, Congenital
Cardiovascular Abnormalities
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 27, 2016