Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052026
Status:
COMPLETED
Last Update Posted:
2008-12-25
First Post:
2003-01-21
Brief Title:
Safety and Efficacy Study of Carvedilol to Treat Children With Congestive Heart Failure
Sponsor:
Shaddy Robert MD
Organization:
Shaddy Robert MD
Study Overview
Official Title:
A Multicenter Placebo-Controlled 8-Month Study of the Effect of Twice Daily Carvedilol in Children With Congestive Heart Failure Due to Systemic Ventricular Systolic Dysfunction
Status:
COMPLETED
Status Verified Date:
2008-12
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:
The purpose of this study is to determine whether a new medicine called carvedilol improves symptoms and heart function in children who have congestive heart failure diminished function of their heart muscle that pumps blood to the body To accomplish this we will give carvedilol to some patients who have diminished heart function and congestive heart failure and see whether symptoms and heart function are better at the end of an 8 month period in those who received carvedilol compared to the other patients who did not receive carvedilol We will be testing 2 different doses of carvedilol compared to no additional medicine
Detailed Description:
Overactivity of the sympathetic nervous system is thought to contribute to the pathophysiology of congestive heart failure CHF Blockade of the sympathetic nervous system with β-adrenergic inhibitors could be expected to ameliorate these detrimental effects in a manner analogous to the effects of the angiotensin converting enzyme inhibitors on the overactive renin-angiotensin system
Carvedilol may be superior to pure beta-blockers in the treatment of CHF through its mechanism of action of blocking not only β-receptors but also α-receptors which would allow vasodilation to reduce the afterload on the failing heart Since beta-blockers may initially produce a negative inotropic effect on the heart long term treatment has been needed to show benefits of removal of the adrenergic stimulation The investigators will monitor the safety and efficacy of carvedilol administration in children with chronic CHF due to systemic ventricular dysfunction
Carvedilol may be superior to pure beta-blockers in the treatment of CHF through its mechanism of action of blocking not only β-receptors but also α-receptors which would allow vasodilation to reduce the afterload on the failing heart Since beta-blockers may initially produce a negative inotropic effect on the heart long term treatment has been needed to show benefits of removal of the adrenergic stimulation The investigators will monitor the safety and efficacy of carvedilol administration in children with chronic CHF due to systemic ventricular dysfunction
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