Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001960
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-01-18
Brief Title:
Studying the Effectiveness of Pacemaker Therapy in Children Who Have Thickened Heart Muscle
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Controlled Cross-Over Study of DDD Pacemaker Therapy in Symptomatic Children With Obstructive Hypertrophic Cardiomyopathy
Status:
COMPLETED
Status Verified Date:
2002-12
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:
A heart condition called hypertrophic cardiomyopathy HCM causes abnormal thickening of the heart muscle which obstructs the flow of blood out of the heart The thickened muscle and the obstruction of blood flow are believed to cause chest discomfort breathlessness fainting and a sensation of heart pounding Treatment options for children with HCM include medicine heart operation and cardiac transplantation However there is no evidence that medicine prevents further thickening of heart muscle operations carry the risk of death and donor hearts are not always available Several studies have shown that pacemaker treatment reduces the obstruction and improves heart complaints in patients with HCM This study investigates further the efficacy of pacemaker treatment in children
Patients will have exercise tests after treatment with beta blocker and verapamil and will be eligible for the study if heart complaints or reduced exercise performance continue
A pacemaker that treats slow heart rhythms will be inserted The patient will be sedated and local anesthesia will be administered to numb the area The procedure takes about an hour
The study will last two years Patients will be placed on one of two pacemaker programs for the first year and another the second year At 3- and 6-month follow-up visits a pacemaker check and echocardiogram will be performed After 1 year patients will be admitted to NIH for 2 to 3 days for exercise tests echocardiogram and cardiac catheterization Also the pacemaker will be changed to the second program At 15- and 18-month follow-up visits a pacemaker check and echocardiogram will be performed After 2 years patients will again be admitted for 2 to 3 days for exercise tests echocardiogram and cardiac catheterization A pregnancy test will be given to females of child-bearing age before each cardiac catheterization and electrophysiology study
At the end of the study the pacemaker will be set to the program that worked better
Risks of pacemaker insertion include lung collapse infection blood vessel damage bleeding heart attack and death Risks of cardiac catheterization include infection bleeding blood clots abnormal heart rhythms perforation of the heart need for surgery and death However the safety record for both these procedures at NIH has been excellent The radiation exposure exceeds the NIH radiation guidelines for children but this exposure in adults has not been associated with any definite adverse effects
Patients will have exercise tests after treatment with beta blocker and verapamil and will be eligible for the study if heart complaints or reduced exercise performance continue
A pacemaker that treats slow heart rhythms will be inserted The patient will be sedated and local anesthesia will be administered to numb the area The procedure takes about an hour
The study will last two years Patients will be placed on one of two pacemaker programs for the first year and another the second year At 3- and 6-month follow-up visits a pacemaker check and echocardiogram will be performed After 1 year patients will be admitted to NIH for 2 to 3 days for exercise tests echocardiogram and cardiac catheterization Also the pacemaker will be changed to the second program At 15- and 18-month follow-up visits a pacemaker check and echocardiogram will be performed After 2 years patients will again be admitted for 2 to 3 days for exercise tests echocardiogram and cardiac catheterization A pregnancy test will be given to females of child-bearing age before each cardiac catheterization and electrophysiology study
At the end of the study the pacemaker will be set to the program that worked better
Risks of pacemaker insertion include lung collapse infection blood vessel damage bleeding heart attack and death Risks of cardiac catheterization include infection bleeding blood clots abnormal heart rhythms perforation of the heart need for surgery and death However the safety record for both these procedures at NIH has been excellent The radiation exposure exceeds the NIH radiation guidelines for children but this exposure in adults has not been associated with any definite adverse effects
Detailed Description:
Studies suggest that DDD pacemaker therapy is effective in improving symptoms and reducing intra-ventricular pressures and pressure gradients in children with obstructive HCM during a period of rapid body growth when the severity of the disease is expected to worsen We propose a randomized cross-over study of DDD pacing versus placebo AAI pacing mode in children who have limited exercise performance andor symptoms despite medical therapy beta-blocker or verapamil Study subjects will receive a pacemaker and will be randomized to one of two pacing modes DDD AAI After a 1-year follow-up evaluation the children will cross-over to the alternative pacing mode and will be re-evaluated after a further year All children will continue to receive optimum medical therapy beta-blocker or verapamil based on improvement in symptoms and exercise performance The subjects will undergo outpatient evaluations exercise tests and echocardiography 3 6 15 and 18 months after pacemaker implantation and inpatient evaluations exercise tests echocardiography and cardiac catheterization 1 year and 2 years after entry into the study Primary end-points will be exercise duration and severity of LV outflow obstruction The patient parents referring physician and individual supervising the exercise tests will be blinded to the pacing mode
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 |
|---|---|---|---|
| 00-H-0007 | None | None | None |