Natural History and Results of Dual Chamber (DDD) Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop...
NCT00001396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2017-07-02
Summary
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
Interventions
- DEVICE
-
Paragon Pacemaker
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
lead NIH
Study Design
- Purpose
- TREATMENT
Eligibility
- Min Age
- 5 Years
- Max Age
- 20 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1993-10-06
- Completion
- 2008-07-23
Countries
- United States
Study Locations
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