Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433043
Status:
TERMINATED
Last Update Posted:
2015-10-30
First Post:
2007-02-08
Brief Title:
BOAT Beta Blocker Uptitration With OptiVol After Cardiac Resynchronization Therapy CRT
Sponsor:
St Lukes-Roosevelt Hospital Center
Organization:
St Lukes-Roosevelt Hospital Center
Study Overview
Official Title:
Beta-blocker Uptitration in Heart Failure Patients Receiving Cardiac Resynchronization Therapy With Optivol Fluid Status Monitoring System
Status:
TERMINATED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Many heart failure patients are unable to reach target beta blocker doses This study will address whether cardiac resynchronization therapy CRT will enable uptitration of beta-blockers to target doses and whether it will favorably affect remodeling by reducing left ventricular end systolic volume LVESV with measurable clinical benefit beyond CRT alone without changes in beta-blocker dose
Detailed Description:
Beta blockers have been proven to have benefit in heart failure HF patients with regard to morbidity and mortality However initiation and uptitration remains a challenge in many patients Worsening of heart failure symptomatic hypotension and symptomatic bradycardia all limit up-titration to the target doses that have been shown to have mortality benefits carvedilol Coreg 25 mg bid metoprolol succinate Toprol-XL 200 mg qd in the large clinical trials COPERNICUS MERIT-HF
It is debated whether the benefit of beta-blockade is solely due to heart rate reduction or more broadly from the cardiac central and peripheral effects of blocking sympathetic activity Clearly there is a remodeling effect on the dilated ventricle Furthermore patients with heart rates of 64 bpm or less are rarely begun on beta-blocker therapy It is not known whether these patients should be given a pacemaker in order to then safely initiate beta-blocker therapy
It is also clear that isolated right ventricular pacing can have deleterious effects on ventricular dyssynchrony and symptomatic heart failure despite medical therapy Biventricular pacing BIVPM also known as cardiac resynchronization therapy CRT is the pacing mode of choice for patients with wide QRS complexes and symptomatic HF
It is hypothesized that CRT therapy allows for increased Beta -blocker dose or initiation of beta-blocker in patients previously intolerant with improved NYHA ejection fraction and remodeling effects The synergy between two established heart failure therapies requires further evaluation in a prospective randomized trial
It is debated whether the benefit of beta-blockade is solely due to heart rate reduction or more broadly from the cardiac central and peripheral effects of blocking sympathetic activity Clearly there is a remodeling effect on the dilated ventricle Furthermore patients with heart rates of 64 bpm or less are rarely begun on beta-blocker therapy It is not known whether these patients should be given a pacemaker in order to then safely initiate beta-blocker therapy
It is also clear that isolated right ventricular pacing can have deleterious effects on ventricular dyssynchrony and symptomatic heart failure despite medical therapy Biventricular pacing BIVPM also known as cardiac resynchronization therapy CRT is the pacing mode of choice for patients with wide QRS complexes and symptomatic HF
It is hypothesized that CRT therapy allows for increased Beta -blocker dose or initiation of beta-blocker in patients previously intolerant with improved NYHA ejection fraction and remodeling effects The synergy between two established heart failure therapies requires further evaluation in a prospective randomized trial
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