An observational study in Cardiomyopathy, Dilated, sponsored by Carelon Research. Completed at 8 sites in 2 countries. Open to participants aged Up to 22 Years. Per ClinicalTrials.gov, last updated 2013-01-25.
Sponsored by Carelon Research · Observational
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 inter-study variability seen in echocardiography.
BACKGROUND:
Cardiomyopathy is an important cause of chronic disability and death in pediatric patients and currently accounts for approximately 50% of cardiac transplants performed during childhood. Left ventricular (LV) 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, data are limited 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 Physicians and Surgeons, New York, 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
Washington University, St. Louis, MO
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 to 18 months apart will have their studies performed by the same ultrasonographer. All studies will be sent to the core laboratory for evaluation of variability in LV mass, volume, and ejection fraction.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 131 is below the median of 153 across 515 observational studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Carelon Research is the lead sponsor of 55 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients up to 22 years of age with dilated cardiomyopathy followed at participating clinical centers or newly diagnosed during the recruitment period
Exclusion Criteria:
Inter-study variability of echo measurements; variance at a single point in time and variance of change in measurements over time
Time frame: Measured for up to 18 months
Relative magnitude of the various sources of variability in echocardiographic outcomes in order to optimize operational procedures that can minimize variance
Time frame: Measured for up to 18 months
Interstudy variability of echocardiographically-derived indices of LV systolic and diastolic function derived from m-mode, spectral Doppler, and tissue Doppler techniques used in pediatric patients with dilated cardiomyopathy
Time frame: Measured for up to 18 months
Relationship of clinical status, including treatment, to the interstudy variability and repeatability of echocardiographic measurements.
Time frame: Measured for up to 18 months
This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Carelon Research