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NCT Number: NCT00001396

Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...

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.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

5 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA: DDD Pacemaker Therapy

Children of either gender, aged 5 to 15 years.

Presence of LV hypertrophy and LV outflow obstruction.

Exclusion criteria

DDD Pacemaker Therapy

Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.

Chronic atrial fibrillation.

Positive pregnancy test.

Inclusion criteria

Cohort Study

Children of either gender, 5 to 20 years (children greater than 15 years will be included if there is access to reliable previous catheterization data).

Presence of LV hypertrophy and LV obstruction.

Exclusion criteria

Cohort Study

Other systemic disease that prevent evaluation by echocardiography or cardiac catheterization.

Chronic atrial fibrillation.

Positive pregnancy test.

Treatment and study plan

Paragon Pacemaker

Device

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy

Important dates

Study start: 1993
Study completion: 2008
First posted: Nov 4, 1999
Registry last updated: Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed