This observational study will provide data (variations in ventricular size and function) that are essential to designing and conducting clinical trials. In addition, the study will evaluate intra and interstudy variability seen in echocardiography.

Condition
Cardiomyopathy, Congestive

Further Study Details: 

BACKGROUND: Cardiomyopathy is an important cause of chronic disabilityand death in pediatric patients and currently accounts for approximately 50% of cardiac transplants performed during childhood. Left ventricular size and function are important independent predictors of outcome and echocardiography is the primary way to assess ventricular function in children. Although there is extensive experience with this technology, there is limited data on how ventricular function changes over time in children which is a major impediment to conducting controlled trials of therapy in children.

This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers:

Hospital for Sick Children, Toronto, Canada

Children''''s Hospital Boston, Boston, MA

Columbia College of Physician and Surgeons, NY, NY

Children''''s Hospital of Philadelphia, Philadelphia, PA

Duke University Medical Center, Durham, NC

Brody School of Medicine at East Carolina University, Greenville, NC

Wake Forest Baptist Medical Center, Winston Salem, NC

Medical University of South Carolina, Charleston, SC

Primary Children''''s Medical Center, Salt Lake City, UT

DESIGN NARRATIVE: This observational study will prospectively evaluate pediatric patients with dilated cardiomyopathy who are undergoing clinically indicated echocardiographic evaluation of LV function. Patients who undergo at least two echocardiograms 3-13 months apart will have their studies performed by the same ultrasonographer. All studies will be sent to the core laboratory for evaluation of variabiltiy in left ventricular mass, volume and ejection fraction.

Ages Eligible for Study:  up to  18 Years,  Genders Eligible for Study:  Both

Criteria

Less than 18 years of age, without congenital heart disease and undergoing echo evaluation

Diagnosis of dilated cardiomyopathy (not hypertrophic or restrictive cardiomyopathy)

Disease onset greater than 2 months prior to screening

Anticipated to undergo repeat echo evaluation at the same institution in the next 3 to 13 months

Please refer to this study by ClinicalTrials.gov identifier  NCT00123071

Massachusetts
      Children''''s Hospital Boston, Boston,  Massachusetts,  United States; Recruiting
New York
      Columbia College of Physicians and Surgeons, New York,  New York,  United States; Recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  United States; Recruiting
Pennsylvania
      Children''''s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  United States; Recruiting
South Carolina
      Medical University of South Carolina, Charleston,  South Carolina,  United States; Recruiting
Utah
      Primary Children''''s Hospital, Salt Lake City,  Utah,  United States; Recruiting
Canada, Ontario
      Hospital for Sick Children, Toronto,  Ontario,  Canada; Recruiting

Study ID Numbers:  236
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 21, 2005
ClinicalTrials.gov Identifier:  NCT00123071
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-07-26