Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy
Several studies have shown that specialized pacemaking devices (DDD pacing) can improve the
symptoms associated with hypertrophic cardiomyopathy (HCM) in adults. In addition, studies
have also shown that specialized pacemaking devices (DDD pacing) can improve conditions of
HCM in children. However, growth of the body and organs, including the heart, is very rapid
during childhood. Therefore the long-term effects of DDD pacing in children are unknown.
The purpose of this study is to examine the growth rate and nutrition of children with HCM.
Due to this heart condition and the restrictions that are often placed on the child's
activity level, children with HCM may grow at a slower rat and may have a greater tendency to
be overweight.
Children participating in the study will have their growth rate and nutritional status
measured before the study begins and throughout the course of the study.
Findings in this research study will not directly benefit the patients participating in it.
However, information gathered as a result of this study may lead to improvements in the
management of children with HCM in the future.
Several studies have shown that dual chamber (DDD) pacemaker therapy relieves LV outflow obstruction and improves symptoms in most adult patients with obstructive hypertrophic cardiomyopathy (HCM). It is however, uncertain whether DDD pacing will be efficacious in children with obstructive HCM, because of evolving cardiac morphology and increased LV hypertrophy and outflow obstruction associated with rapid body growth. We propose to monitor clinical progress, and cardiac morphologic and hemodynamic changes over several years following implantation of a DDD pacemaker in children who present with obstructive HCM between the ages of 5 to 15 years. Functional status, myocardial ischemia, arrhythmias, and LV outflow obstruction will be evaluated by exercise tests, echocardiography, thallium scintigraphy, Holter monitoring, electrophysiologic and cardiac catheterization studies. The results of pacemaker therapy will be compared with the findings in a cohort of young patients with obstructive HCM who elect not to be treated with DDD pacemaker. ;
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