Hypertrophic Cardiomyopathy Clinical Trial
Official title:
Obstructive Hypertrophic Cardiomyopathy (HCM) in Children: Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy
Verified date | July 23, 2008 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | July 23, 2008 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | All |
Age group | 5 Years to 20 Years |
Eligibility |
- 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. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Fananapazir L, Cannon RO 3rd, Tripodi D, Panza JA. Impact of dual-chamber permanent pacing in patients with obstructive hypertrophic cardiomyopathy with symptoms refractory to verapamil and beta-adrenergic blocker therapy. Circulation. 1992 Jun;85(6):2149-61. — View Citation
McAreavey D, Fananapazir L. Altered cardiac hemodynamic and electrical state in normal sinus rhythm after chronic dual-chamber pacing for relief of left ventricular outflow obstruction in hypertrophic cardiomyopathy. Am J Cardiol. 1992 Sep 1;70(6):651-6. — View Citation
Slade AK, Sadoul N, Shapiro L, Chojnowska L, Simon JP, Saumarez RC, Dodinot B, Camm AJ, McKenna WJ, Aliot E. DDD pacing in hypertrophic cardiomyopathy: a multicentre clinical experience. Heart. 1996 Jan;75(1):44-9. — View Citation
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