Healthy Clinical Trial
Official title:
Myocardial Ultrasonic Tissue Characterization in Patients With a Genetic Predisposition for the Development of Hypertrophic Cardiomyopathy
The human heart is divided into four chambers. One of the four chambers, the left ventricle,
is the chamber mainly responsible for pumping blood out of the heart into the circulation.
Hypertrophic cardiomyopathy is a genetically inherited disease causing an abnormal
thickening of heart muscle, especially the muscle making up the left ventricle. When the
left ventricle becomes abnormally large, it is called left ventricular hypertrophy (LVH).
Patients with HCM can be born with an enlarged left ventricle or they may develop the
condition in childhood or adolescence, usually during the time when the body is rapidly
growing. However, not all patients with the abnormal genes linked to HCM have the
characteristic LVH.
Currently, it is impossible to tell if a patient with the genes for HCM will develop LVH.
A recently developed ultrasound tool called an integrated backscatter analysis (IBS), may
allow researchers to determine those children who may later develop HCM and LVH. In order to
test this, researchers plan to use IBS to study normal children with relatives diagnosed
with HCM.
This study will compare the results of IBS done on normal children with relatives diagnosed
with HCM , normal children, and children with evidence enlarged heart muscle (HCM).
Status | Completed |
Enrollment | 195 |
Est. completion date | August 2002 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
INCLUSION CRITERIA: Three groups of subjects (aged 1-15 years) will be studied: normal children, children with HCM, and children that are family members of patients with HCM, but do not themselves have any evidence of LVH. CONTROL GROUP (NORM GROUP): Normal children under the age of 15 who have a normal two-dimensional echocardiogram will be included in the study. HYPERTROPHIC CARDIOMYOPATHY GROUP (HCM GROUP): Patients with HCM (unexplained LVH on two-dimensional echocardiogram) under the age of 15 will be included. Family History of Hypertrophic Cardiomyopathy Group (FHCM GROUP: Normal children under the age of 15 who have a first-degree relative with HCM and a normal two-dimensional echocardiogram will be included. EXCLUSION CRITERIA - CONTROL GROUP: Exclusion criteria will be any historical or echocardiographic evidence of congenital or valvular heart disease or any form of cardiomyopathy. EXCLUSION CRITERIA - HCM GROUP: Exclusion criteria will be any evidence of congenital or valvular heart disease that may explain the presence of LVH. EXCLUSION CRITERIA - FHCM GROUP: Exclusion criteria will be any historical or echocardiographic evidence of congenital or valvular heart disease or other form of cardiomyopathy. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Heart, Lung and Blood Institute (NHLBI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Miller JG, Pérez JE, Sobel BE. Ultrasonic characterization of myocardium. Prog Cardiovasc Dis. 1985 Sep-Oct;28(2):85-110. Review. — View Citation
Panza JA, Maron BJ. Relation of electrocardiographic abnormalities to evolving left ventricular hypertrophy in hypertrophic cardiomyopathy during childhood. Am J Cardiol. 1989 May 15;63(17):1258-65. — View Citation
Vitale DF, Bonow RO, Calabrò R, De Cristofaro M, Pacileo G, Caso P, Gerundo G, Bordini C, Losi MA, Rengo C, Rengo F. Myocardial ultrasonic tissue characterization in pediatric and adult patients with hypertrophic cardiomyopathy. Circulation. 1996 Dec 1;94(11):2826-30. — View Citation
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