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Adult Congenital Heart Disease Registry (QuERI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Actelion
Sponsor:
Collaborator:
Canadian Heart Research Centre
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01659411
First received: July 12, 2012
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

Multi-center, observational, U.S.-based longitudinal program. Data will be collected prospectively for 3 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 from adult patients enrolled with a history of repaired Congenital Heart Disease (CHD).


Condition Intervention
Pulmonary Arterial Hypertension
Congenital Heart Disease
Other: observational

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Adult Congenital Heart Disease Quality Enhancement Research Initiative

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • To characterize the clinical course in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]
    outcome measure: clinical outcomes: Assessment of function status, medications, and laboratory results, as well as an evaluation of medical history, physical examination, ECG, and echocardiography, in adult congenital heart disease patients at risk for pulmonary hypertension.


Secondary Outcome Measures:
  • To characterize the clinical outcomes in a cohort of adult patients with repaired CHD at risk for developing PAH [ Time Frame: screening (visit 1) through end of study (3 years) ] [ Designated as safety issue: No ]
    outcome measure: clinical rate: To assess the rate of newly diagnosed pulmonary arterial hypertension in a cohort of adults with repaired congenital heart disease at risk for pulmonary arterial hypertension. To also compare clinical outcomes in patients who do and do not meet prespecified echocardiography criteria for suspected pulmonary arterial hypertension.


Estimated Enrollment: 800
Study Start Date: December 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Adult CHD Patients
observational
Other: observational
yearly clinical visits
Other Name: observational

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

adult CHD patients meeting inclusion and exclusion criteria may be enrolled

Criteria

Inclusion Criteria:

  1. Male and female adults (≥ 18 years of age)
  2. Patients with documented history (at least one year) of an isolated, repaired congenital heart defect such as ASD, VSD, PDA, AVC (AVSD)
  3. History of a large defect prior to closure as evidenced by any one of the following:

    • Size of: ASD > 2 cm; VSD > 1 cm; PDA > 0.6 cm
    • Shunt 2:1 or greater
    • Pre-operative PH (PAS > 40 mmHg) or documented shunt- related heart failure (radiographic evidence)
    • Pre-operative atrial fibrillation or flutter
  4. High risk features (any one the following):

    • Age > 40 years
    • Later surgical repair:

1. ≥ 2 years of age for PDA or VSD 2. ≥ 1 year of age for AVC 3. ≥ 10 years of age for ASD

  • sinus venosus defect
  • primum defect
  • WHO functional class > 1
  • atrial fibrillation or flutter 5. Echocardiographic evidence of high risk features. Any one of the following:
  • Degree of TR that is mild or greater
  • Right ventricular (RV) systolic dysfunction
  • Evidence of RV dilatation: Any one of the following:

    1. Evidence of RV dilation by general, qualitative assessment
    2. RV end diastolic diameter > 3.2 cm on apical 4 chamber view at the tips of the tricuspid valve
    3. RV to LV ratio at end-diastole > 0.6 (RV and LV end diastolic dimensions measured from apical 4 chamber view, 1 cm apical of the respective valve annuli)
  • Any abnormality in the motion of the inter-ventricular septum 6. Ability and desire to execute the consent for follow up

Exclusion Criteria:

  1. 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
  2. Diagnosis of PAH (defined as RHC demonstrating mPAP ≥ 25 mm Hg and PCWP ≤ 15 and PVR > 3 WU or PVR (indexed) > 4 WU or treatment with PAH specific therapy) after surgical repair and prior to visit 1.
  3. Prior inclusion in this registry.
  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: NCT01659411

Contacts
Contact: Anatoly Langer, MD 416-999-6264 langera@chrc.net

  Hide Study Locations
Locations
United States, Arkansas
The University of Arkansas for Medical Sciences - Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
Contact: R. Thomas Collins, MD    501-364-1479    rtcollins@uams.edu   
Principal Investigator: R. Thomas Collins, MD         
United States, California
Ahmanson / UCLA Adult Congenital Heart Disease Center Recruiting
Los Angeles, California, United States, 90095
Contact: Jamil Aboulhosn, MD    310-825-2019    JAboulhosn@mednet.ucla.edu   
Principal Investigator: Jamil Aboulhosn, MD         
University of Southern California ACHD Care Program Recruiting
Los Angeles, California, United States, 90033
Contact: Philip Chang, MD    323-442-6130    philip.chang@med.usc.edu   
Principal Investigator: Philip Chang, MD         
Berkeley Cardiovascular Medical Group Recruiting
Oakland, California, United States, 94609
Contact: Luisa Munoz    510-204-1691    munozl@bcvmg.com   
Principal Investigator: Luisa Munoz, MD         
United States, Colorado
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
Contact: Joseph Kay, MD    720-848-6585    joseph.kay@ucdenver.edu   
Principal Investigator: Joseph Kay, MD         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact: Felice A Heller, MD    860-545-9400    fheller@ccmckids.org   
Principal Investigator: Felice A Heller, MD         
Yale School of Medicine - Adult Congenital Heart Disease Program Recruiting
New Haven, Connecticut, United States, 06510
Contact: Constance Weismann, MD    203-785-2022    constance.weismann@yale.edu   
Principal Investigator: Constance Weismann, MD         
United States, District of Columbia
Children's National Medical Center and Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Anitha John, MD    202-476-3543    anjohn@childrensnational.org   
Principal Investigator: Anitha John, MD         
United States, Florida
Bay Area Cardiology Assoc., P.A. Recruiting
Brandon, Florida, United States, 33511
Contact: Robert M Dewhurst    813-684-6000    bac.research@bayareacardiology.com   
Principal Investigator: Robert M Dewhurst, MD         
University of Florida, Shands Hospital Recruiting
Gainsville, Florida, United States, 32610
Contact: Arwa Saidi, MD    352-273-7770    dalylc@ufl.edu   
Principal Investigator: Arwa Saidi, MD         
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Larry A Latson, MD    954-265-3437    llatson@mhs.net   
Principal Investigator: Larry A Latson, MD         
United States, Hawaii
The Queen's Heart Physician Practice Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Christian Spies, MD    808-545-8900    spies.cvm@gmail.com   
Principal Investigator: Christian Spies, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Damien Kenny, MD    312-942-6800    Damien_Kenny@rush.edu   
Principal Investigator: Damien Kenny, MD         
Advocate Medical Group Recruiting
Oak Lawn, Illinois, United States, 60453
Contact: Muhyaldeen Dia, Dia    708-636-7575    muhyaldeen@gmail.com   
Principal Investigator: Muhyaldeen Dia, MD         
United States, Kansas
The University of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Kevin Mulhern, MD    913-588-9600    kmulhern@kumc.edu   
Principal Investigator: Kevin Mulhern, MD         
United States, Kentucky
University of Louisville, Pediatric Cardiology Recruiting
Louisville, Kentucky, United States, 40202
Contact: Walter Sobczyk, MD    502-852-3876    Walt.Sobczyk@louisville.edu   
Principal Investigator: Walter Sobczyk, MD         
United States, Maine
Pediatric Cardiology Associates Recruiting
Portland, Maine, United States, 04102
Contact: Adrian Moran, MD    207-883-5541    morana1@mmc.org   
Principal Investigator: Adrian Moran, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stacy Fisher, MD    410-328-8788    sfisher@medicine.umaryland.edu   
Principal Investigator: Stacy Fisher, MD         
United States, Massachusetts
Center for Adults with Congenital Heart Disease Recruiting
Boston, Massachusetts, United States, 02111
Contact: Jeffrey Kuvin, MD    617-636-5846    jkuvin@tuftsmedicalcenter.org   
Principal Investigator: Jeffrey Kuvin, MD         
United States, Michigan
University of Michigan Adult Congenital Program Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Timothy Cotts, MD    734-936-1619    cottstim@med.umich.edu   
Principal Investigator: Timothy Cotts, MD         
United States, Minnesota
University of Minnesota Physicians Heart Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Cindy Martin, MD    612-625-6173    cmmartin@umn.edu   
Principal Investigator: Cindy Martin, MD         
United States, Missouri
Mid-America Heart Institute / St Luke's Hospital / Saint Luke's Cardiovascular Consultants Recruiting
Kansas City, Missouri, United States, 64111
Contact: Anthony Magalski, MD    816-931-1883    amagalski@saint-lukes.org   
Principal Investigator: Anthony Magalski, MD         
Barnes-Jewish Hospital/Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ari Cedars, MD    314-362-1291    acedars@dom.wustl.edu   
Principal Investigator: Ari Cedars, MD         
United States, Nevada
Childrens Heart Center Nevada Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Abraham Rothman, MD    702-732-1290    arothman@childrensheartcenter.com   
Principal Investigator: Abraham Rothman, MD         
United States, New York
Capital District Pediatric Cardiology Associates Recruiting
Albany, New York, United States, 12208
Contact: Robin Doyle, MD    518-489-3293    doylero@hotmail.com   
Principal Investigator: Robin Doyle, MD         
Montefiore Medical Center - Moses Division;The University Hospital for Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Ronald Zolty, MD    718-430-3544    rzolty@montefiore.org   
Principal Investigator: Ronald Zolty, MD         
Bassett Healthcare Network - Bassett Medical Center Recruiting
Cooperstown, New York, United States, 13326
Contact: Dhananjai Menzies, MD    607-547-6965    dhananjai.menzies@bassett.org   
Principal Investigator: Dhananjai Menzies, MD         
Steven and Alexandra Cohen Children's Midical Center of New York, Adult Congenital Heart Disease Program Recruiting
New Hyde Park, New York, United States, 11040
Contact: Scott Pilgrim, MD    718-470-7350    spilgrim@nshs.edu   
Principal Investigator: Scott Pilgrim, MD         
Lenox Hill Heart and Vascular Institute-LIJ North Shore Recruiting
New York, New York, United States, 10075
Contact: Carlos Ruiz, MD    212-434-6839    CRuiz@NSHS.edu   
Principal Investigator: Carlos Ruiz, MD         
Mount Sinai Pulmonary Hypertension Program Recruiting
New York, New York, United States, 10029
Contact: Barry Love, MD    212-241-7300    barry.love@mssm.edu   
Principal Investigator: Barry Love, MD         
Schneeweiss Adult Congenital Heart Center - Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Marlon Rosenbaum, MD    212-305-6936    msr5@columbia.edu   
Principal Investigator: Marlon Rosenbaum, MD         
Pulmonary Health Physicians, PC Recruiting
Syracuse, New York, United States, 13210
Contact: Sherif El Bayadi, MD    315-234-0816    sgelbayadi@yahoo.com   
Principal Investigator: Sherif El Bayadi, MD         
United States, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28803
Contact: Benjamin Trichon, MD    828-274-6000    bht@avlcard.com   
Principal Investigator: Benjamin Trichon, MD         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Michael Camitta, MD    919-684-3574    michael.camitta@duke.edu   
Principal Investigator: Michael Camitta, MD         
East Carolina Heart Institute of East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Contact: Charlie J Sang, MD    252-744-5601    sangc@ecu.edu   
Principal Investigator: Charlie J Sang, MD         
United States, Ohio
Cincinnati Adolescent and Adult Congenital Heart Disease Program, The Heart Institute at Cincinnati Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Gary Webb, MD    513-803-1777    gary.webb@cchmc.org   
Principal Investigator: Gary Webb, MD         
The Cleveland Clinic Adult Congenital Heart Disease Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Richard Krasuski, MD    216-445-7430    krasusr@ccf.org   
Principal Investigator: Richard Krasuski, MD         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Curt Daniels, MD    614-293-4727    curt.daniels@osumc.edu   
Principal Investigator: Curt Daniels, MD         
The Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43215
Contact: Curt Daniels, MD    614-722-5622    curt.daniels@nationwidechildrens.org   
Principal Investigator: Curt Daniels, MD         
United States, Pennsylvania
Central Bucks Specialists Recruiting
Doylestown, Pennsylvania, United States, 18901
Contact: Renee Sangrigoli    215-345-6050    rsangmd@aol.com   
Principal Investigator: Renee Sangrigoli, MD         
The Pennsylvania State University College of Medicine and The Pennsylvania State Milton S. Herhsey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: William Davidson, MD    717-531-5888    wdavidson@hmc.psu.edu   
Principal Investigator: William Davidson, MD         
Hospital of University of Pennsylvania; Childrens Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Yuli Kim, MD    301-996-4225    Yuli.Kim@uphs.upenn.edu   
Principal Investigator: Yuli Kim, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Rene Alvarez, MD    215-707-2006    Rene.Alvarez@tuhs.temple.edu   
Principal Investigator: Rene Alvarez, MD         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: David Gregg, MD    843-876-4788    greggda@musc.edu   
Principal Investigator: David Gregg, MD         
United States, Tennessee
Methodist Lebonheur Healthcare, UT Lebonheur Pediatric Specialists Recruiting
Memphis, Tennessee, United States, 38103
Contact: Benjamin Waller, MD    901-287-5958    benjamin.waller@lebonheur.org   
Principal Investigator: Benjamin Waller, MD         
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Larry W Markham, MD    615-344-3456    Larry.Markham@Vanderbilt.edu   
Principal Investigator: Larry W Markham, MD         
United States, Texas
Texas Children's Hospital/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77005
Contact: Wayne J Franklin, MD    832-826-1949    wjf@bcm.tmc.edu   
Principal Investigator: Wayne J Franklin, MD         
United States, Virginia
University of Virginia Health Systems Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Robert W Battle, MD    434-760-0538    battle@virginia.edu   
Principal Investigator: Robert W Battle, MD         
The Cardiovascular Group Central Recruiting
Lynchburg, Virginia, United States, 24501
Contact: Mark Townsend    434-200-5252    Mark.Townsend@CentraHealth.com   
Principal Investigator: Mark Townsend, MD         
Children's Specialty Group PLLC, Children's Hospital of the King's Daughters Recruiting
Norfolk, Virginia, United States, 23507
Contact: Alexander R Ellis, MD    757-668-7214    ellisar@evms.edu   
Principal Investigator: Alexander R Ellis, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Eric Krieger, MD    206-221-6396    ekrieger@cardiology.washington.edu   
Principal Investigator: Eric Krieger, MD         
United States, West Virginia
West Virginia University Department of Pediatrics Recruiting
Morgantown, West Virginia, United States, 26506
Contact: John Phillips, MD    304-293-7036    jphillips@hsc.wvu.edu   
Principal Investigator: John Phillips, MD         
Sponsors and Collaborators
Actelion
Canadian Heart Research Centre
Investigators
Study Chair: Michael J Landzberg, MD Boston Adult Congenital Heart Service/PH Service
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01659411     History of Changes
Other Study ID Numbers: AC-052-433, CHRC2011-ACHD001
Study First Received: July 12, 2012
Last Updated: January 6, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Actelion:
Pulmonary Arterial Hypertension
Congenital Heart Disease

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

ClinicalTrials.gov processed this record on November 24, 2014