Variability of Ventricular Mass, Volume, & Ejection Fraction in Pediatric Cardiomyopathy Patients-Pediatric Heart Network

Completed

Conditions studied: Cardiomyopathy, Dilated

In brief

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.

Key facts

Study ID

NCT00123071

Run by

Carelon Research

People needed

131

Starts

2005-05-01

Expected to finish

2009-06-01

Last updated by the study team

2013-01-25

Who can join

Age: any, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Less than 22 years of age
• Any race
• Diagnosis of dilated cardiomyopathy
• LV and diastolic diameter greater than 5.5 cm (or z-score for BSA greater than 2) on the primary image acquisition from the first study echocardiogram
• LV ejection fraction less than 50% (or z-score for age less than -2) or shortening fraction less than 28% (or z-score for age less than -2) as measured on the primary image acquisition from the first study echocardiogram
• Disease onset greater than 2 months prior to screening
• Anticipated to undergo repeat evaluation at the same institution at least 3 months but not more than 13 months later
• Informed consent of parent(s) or legal guardian and assent of subject if required

You may not qualify if…

• Hypertrophic cardiomyopathy
• Restrictive cardiomyopathy
• Myocardial noncompaction (LV hypertrabeculation); patient is eligible for the study as long as the echocardiogram performed at the time of screening has no evidence of myocardial noncompaction
• Ventricular paced rhythm
• Atrial or ventricular ectopy at ratio greater than 1:4
• Suspected acute myocarditis
• Tachycardia-induced cardiomyopathy
• Congenital heart disease (repaired or unrepaired)
• Currently on intravenous inotropic support
• Current left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO)
• Heart transplant waiting list status of 1A or 1B
• Co-morbid condition that precludes the ability to successfully obtain an echocardiogram according to the specifications of the study protocol

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.