Status:
COMPLETED
Variability of Ventricular Mass, Volume, & Ejection Fraction in Pediatric Cardiomyopathy Patients-Pediatric Heart Network
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Conditions:
Cardiomyopathy, Dilated
Eligibility:
All Genders
Up to 22 years
Brief Summary
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...
Detailed Description
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. ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT00123071
Start Date
May 1 2005
End Date
June 1 2009
Last Update
January 25 2013
Active Locations (8)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Washington University
St Louis, Missouri, United States, 63110
3
Columbia College of Physicians and Surgeons
New York, New York, United States, 10032
4
Duke University Medical Center
Durham, North Carolina, United States, 27710