Investigation Into the Use of Ultrasound Technique in the Evaluation of Heart Disease

Completed

Conditions studied: Healthy, Hypertrophic Cardiomyopathy, Left Ventricular Hypertrophy

In brief

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).

Key facts

Study ID

NCT00001632

Run by

National Heart, Lung, and Blood Institute (NHLBI)

People needed

195

Starts

1997-09-01

Expected to finish

2002-08-01

Last updated by the study team

2008-03-04

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

Where it is running

• National Heart, Lung and Blood Institute (NHLBI) — Bethesda, Maryland, United States

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.