Completed
Led by National Heart, Lung, and Blood Institute (NHLBI) · Updated on 2017-07-02
100
Participants Needed
1
Research Sites
N/A
Total Duration
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.
CONDITIONS
Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Total: 1 location
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Status Unknown
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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L Fananapazir, R O Cannon, D Tripodi...
https://pubmed.ncbi.nlm.nih.gov/1350522A K Slade, N Sadoul, L Shapiro...
https://pubmed.ncbi.nlm.nih.gov/8624871D McAreavey, L Fananapazir
https://pubmed.ncbi.nlm.nih.gov/1510015