Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by Actelion
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01623492
First received: May 9, 2012
Last updated: May 7, 2013
Last verified: May 2013
  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
Eisenmenger
Other: Management

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
diagnosis of Eisenmenger Syndrome
subjects with diagnosis of Eisenmenger Syndrome
Other: Management
  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

  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

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 Not yet recruiting
Little Rock, Arkansas, United States, 72202
Contact: R. Thomas Collins    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    310-825-5950    JAboulhosn@mednet.ucla.edu   
Principal Investigator: Jamil Aboulhosn, MD         
University of Southern California Adult Congenital Heart Disease Care Program Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Philip Chang    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    510-549-4220    munozl@bcvmg.com   
Principal Investigator: Luisa Munoz, MD         
Lucile Packard Children's Hospital Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Jeffrey A Feinstein, MD    650-723-7913    jeff.feinstein@stanford.edu   
Principal Investigator: Jeffrey A Feinstein, MD         
Centre for Adult Congenital Heart Disease at California Pacific Recruiting
San Francisco, California, United States, 94115
Contact: Robert Popper    415-923-3002    popperr@sutterhealth.org   
Principal Investigator: Robert Popper, MD         
University of California, San Francisco Not yet recruiting
San Francisco, California, United States, 94143-0214
Contact: Ian Harris    415-353-9156    harrisi@medicine.ucsf.edu   
Principal Investigator: Ian Harris, MD         
United States, Colorado
University of Colorado Hospital Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Joseph Kay    720-848-6585    joseph.kay@ucdenver.edu   
Principal Investigator: Joseph Kay, MD         
United States, Connecticut
Yale School of Medicine - Adult Congenital Heart Disease Program Recruiting
New Haven, Connecticut, United States, 06510
Contact: Constance Weismann    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 Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Anitha John    202-476-3543    anjohn@childrensnational.org   
Principal Investigator: Anitha John, MD         
United States, Florida
Memorial Regional Hospital Not yet recruiting
Hollywood, Florida, United States, 33021
Contact: Kak-Chen Chan    954-265-3437    KCChan@mhs.net   
Principal Investigator: Kak-Chen Chan, MD         
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Damien Kenny    312-942-6800    Damien_Kenny@rush.edu   
Principal Investigator: Damien Kenny, MD         
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Contact: Amit Patel    773-702-1843    jackie.smith@uchospitals.edu   
Principal Investigator: Amit Patel, MD         
United States, Kansas
The University of Kansas Hospital Not yet recruiting
Kansas City, Kansas, United States, 66160
Contact: Kevin Mulhern    913-588-9600    kmulhern@kumc.edu   
Principal Investigator: Kevin Mulhern, MD         
United States, Kentucky
University of Louisville, Pediatric Cardiology Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Walter Sobczyk    502-852-3876    Walt.Sobczyk@louisville.edu   
Principal Investigator: Walter Sobczyk, MD         
United States, Louisiana
Ochsner Medical Center Not yet recruiting
New Orleans, Louisiana, United States, 70121
Contact: Thomas W. Young    504-842-5200    thyoung@ochsner.org   
Principal Investigator: Thomas W Young, MD         
United States, Maine
Pediatric Cardiology Associates Not yet recruiting
Portland, Maine, United States, 04102
Contact: Adrian Moran    207-773-2723    morana1@mmc.org   
Principal Investigator: Adrian Moran, MD         
United States, Maryland
University of Maryland School of Medicine Recruiting
Baltimore, Maryland, United States, 21201
Contact: Stacy Fisher    410-328-8788    sfisher@medicine.umaryland.edu   
Principal Investigator: Stacy Fisher, MD         
United States, Massachusetts
Children's Hospital Boston and Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Alexander Opotowsky    617-355-6508    alexander.opotowsky@chboston.org   
Principal Investigator: Alexander Opotowsky, MD         
Massachusetts General Hospital Heart Center Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Ami Bhatt    617-726-8510    abhatt@partners.org   
Principal Investigator: Ami Bhatt, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Vallerie McLaughlin    734-936-5383    vmclaugh@med.umich.edu   
Principal Investigator: Vallerie McLaughlin, MD         
United States, Minnesota
University of Minnesota Physicians Heart Fairview Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Cindy M Martin    612-625-6173    cmmartin@umn.edu   
Principal Investigator: Cindy M Martin, MD         
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Frank Cetta    507-266-0676    cetta.frank@mayo.edu   
Principal Investigator: Frank Cetta, MD         
United States, Missouri
Mid-America Heart Institute / Saint Luke's Hospital / Saint Luke's Cardiovascular Consultants Recruiting
Kansas City, Missouri, United States, 64111
Contact: Anthony Magalski    816-931-1883    amagalski@saint-lukes.org   
Principal Investigator: Anthony Magalski, MD         
Barnes-Jewish Hospital/St. Louis Children's Hospital / Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Ari Cedars    314-362-1291    acedars@dom.wustl.edu   
Principal Investigator: Ari Cedars, MD         
United States, Nebraska
Children's Hospital & Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68114
Contact: Scott Fletcher    402-955-4334    sfletcher@childrensomaha.org   
Principal Investigator: Scott Fletcher, MD         
United States, Nevada
Children's Heart Center Nevada Recruiting
Las Vegas, Nevada, United States, 89109
Contact: Abraham Rothman    702-732-1290    arothman@childrensheartcenter.com   
Principal Investigator: Abraham Rothman, MD         
United States, New York
Montefiore Medical Center at Albert Einstein College of Medicine - Weiler Division Recruiting
Bronx, New York, United States, 10461
Contact: Ronald Zolty    718-904-3293    rzolty@montefiore.org   
Principal Investigator: Ronald Zolty, MD         
Bassett Healthcare Network - Bassett Medical Center Recruiting
Cooperstown, New York, United States, 13326
Contact: Dhananjai Menzies    607-547-6965    Dhananjai.menzies@bassett.org   
Principal Investigator: Dhananjai Menzies, MD         
Cohen's Children's Medical Center of New York - Adult Congenital Heart Disease Program Not yet recruiting
New Hyde Park, New York, United States, 11040
Contact: Scott Pilgrim    718-470-7350    spilgrim@nshs.edu   
Principal Investigator: Scott Pilgrim, MD         
Columbia University Pulmonary Hypertension Center Recruiting
New York, New York, United States, 10032
Contact: Erika Berman-Rosenzweig    212-305-4436    esb14@columbia.edu   
Principal Investigator: Erika Berman-Rosenzweig, MD         
Lenox Hill Hospital Not yet recruiting
New York, New York, United States, 10075
Contact: Carlos Ruiz    212-434-6839    CRuiz@NSHS.edu   
Principal Investigator: Carlos Ruiz, MD         
Mount Sinai Medical Center Recruiting
New York, New York, United States, 10029
Contact: Ajith Nair    212-241-7300    ajith.nair@mssm.edu   
Principal Investigator: Ajith Nair, MD         
United States, North Carolina
Asheville Cardiology Associates Recruiting
Asheville, North Carolina, United States, 28803
Contact: Benjamin Trichon    828-274-6000    bht@avlcard.com   
Principal Investigator: Benjamin Trichon, MD         
Medical University of South Carolina Recruiting
Charleston, North Carolina, United States, 29425
Contact: Andrew Savage    843-792-2300    savageaj@musc.edu   
Principal Investigator: Andrew Savage, MD         
Duke University Medical Center Not yet recruiting
Durham, North Carolina, United States, 27707
Contact: Cary Ward    919-668-6355    c.ward@duke.edu   
Principal Investigator: Cary Ward, MD         
East Carolina University Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact: Charlie J. Sang    252-744-5601    sangc@ecu.edu   
Principal Investigator: Charlie J Sang, MD         
United States, Ohio
CINCINNATI Children's Hospital Medical Center Not yet recruiting
Cincinnati, Ohio, United States, 45229
Contact: Gary Webb    513-636-4432    gary.webb@cchmc.org   
Principal Investigator: Gary Webb, MD         
UC Health/University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jean Elwing    513-558-4831    jean.elwing@uc.edu   
Principal Investigator: Jean Elwing, MD         
Rainbow Babies and Childrens Hospital Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Manish Bansa    216-844-3528    manish.bansal@uhhospitals.org   
Principal Investigator: Manish Bansal, MD         
The Cleveland Clinic Adult Congenital Heart Disease Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Richard Krasuski    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    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    614-722-5622    curt.daniels@nationwidechildrens.org   
Principal Investigator: Curt Daniels, MD         
United States, Oregon
Oregon Health and Sciences University Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Elizabeth Cannard    503-494-5893    cannarde@ohsu.edu   
Principal Investigator: Craig Broberg, MD         
United States, Pennsylvania
The Pennsylvania State University College of Medicine and The Pennsylvania State Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: William Davidson    717-531-5888    wdavidson@hmc.psu.edu   
Principal Investigator: William Davidson, MD         
Hospital of the University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Yuli Kim    301-996-4225    yuli.kim@uphs.upenn.edu   
Principal Investigator: Yuli Kim, MD         
Temple University Hospital Not yet recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Rene Alvarez    215-707-2006    Rene.Alvarez@tuhs.temple.edu   
Principal Investigator: Rene Alvarez, MD         
United States, Tennessee
Methodist Lebonheur Healthcare, UT Lebonheur Pediatric Specialists Not yet recruiting
Memphis, Tennessee, United States, 38103
Contact: Benjamin R Waller    901-287-5958    Benjamin.Waller@mlh.org   
Principal Investigator: Benjamin R Waller, MD         
Vanderbilt University Medical Center Not yet recruiting
Nashville, Tennessee, United States, 37232
Contact: Larry W Markham    615-344-3456    Larry.Markham@Vanderbilt.edu   
Principal Investigator: Larry W Markham, MD         
United States, Texas
University of Texas Southwestern Medical Center Not yet recruiting
Dallas, Texas, United States, 75390-9047
Contact: Beth Brickner    214-645-7500    beth.brickner@utsouthwestern.edu   
Principal Investigator: Beth Brickner, MD         
Texas Children's Hospital/Baylor College of Medicine Recruiting
Houston, Texas, United States, 77005
Contact: Wayne Franklin    832-826-1949    wjf@bcm.edu   
Principal Investigator: Wayne Franklin, MD         
United States, Vermont
Fletcher Allen Health Care Not yet recruiting
Burlington, Vermont, United States, 05401
Contact: William Hopkins    802-847-3655    william.hopkins@vtmednet.org   
Principal Investigator: William Hopkins, MD         
United States, Virginia
University of Virginia Health Systems Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Robert W Battle    434-760-0538    battle@virginia.edu   
Principal Investigator: Robert W Battle, MD         
The Cardiovascular Group Centra 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 Not yet recruiting
Norfolk, Virginia, United States, 23507
Contact: Alexander R Ellis    757-668-7213    ellisar@evms.edu   
Principal Investigator: Alexander R Ellis, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98105
Contact: Eric Krieger    917-660-1422    ekrieger@u.washington.edu   
Principal Investigator: Eric Krieger, MD         
Providence Sacred Heart Medical Center and Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Carlos Garabedian    509-474-6707    carl.garabedian@providence.org;   
Principal Investigator: Carols Garabedian, MD         
United States, Wisconsin
Children's Hospital of Wisconsin, Medical College of Wisconsin Adult Congenital Heart Disease Program Not yet recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael Earing, MD    414-266-1608    mearing@chw.org   
Principal Investigator: Michael Earing, MD         
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Scott Tsurutani Actelion Pharmaceuticals U.S., Inc.
  More Information

No publications provided

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: May 7, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Actelion:
Eisenmenger

Additional relevant MeSH terms:
Eisenmenger Complex
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases

ClinicalTrials.gov processed this record on November 23, 2014