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Eisenmenger Quality Enhancement Research Initiative (ES-QuERI)

This study is currently recruiting participants.
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
History of Changes
  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

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
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            
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            
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            
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
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            
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            
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            
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            
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            
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            
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            
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            
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
Heart Defects, Congenital
Cardiovascular Abnormalities
 Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on June 13, 2013