Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001396
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
1999-11-03
Brief Title:
Natural History and Results of Dual Chamber DDD Pacemaker Therapy of Children With Obstructive Hypertrophic Cardiomyop
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Obstructive Hypertrophic Cardiomyopathy HCM in Children Natural History and Results of Dual Chamber DDD Pacemaker Therapy
Status:
COMPLETED
Status Verified Date:
2008-07-23
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 childs 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
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 childs 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
Detailed Description:
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 94-H-0001 | None | None | None |