Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225667
Status:
UNKNOWN
Last Update Posted:
2005-11-23
First Post:
2005-09-12
Brief Title:
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension and Permanent Pacemakers
Sponsor:
Connolly Stuart MD
Organization:
Connolly Stuart MD
Study Overview
Official Title:
Irbesartan for the Prevention of Atrial Arrhythmias and Cardiac Electrical Remodeling in Patients With Hypertension Permanent Pacemakers and Risk Factors for Developing Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
NOT_YET_RECRUITING
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 irbesartan will reduce the rate of recurrent atrial high rate episodes and the development of clinical sustained atrial fibrillation in patients with hypertension and permanent pacemaker
Detailed Description:
Patients with permanent pacemakers have a high risk of atrial fibrillation AF particularly those with hypertension sinus node dysfunction and those with short episodes of atrial arrhythmias known as atrial high-rate episodes AHRE AHRE are felt to be a precursor to AF and may be both the result and a cause of changs in the atrial electrophysiology and structure known as cardiac remodelingthat are associated with the development of AF
Evaluating this process in human AF has been limited by the cumbersome nature of performing serial invasive electrophysiologic studies However modern pacemakers now permit rapid non-invasive electrophysiologic testing and can also accurately document AHRE which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF In addition this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling
Comparison Irbesartan compared to placebo
Evaluating this process in human AF has been limited by the cumbersome nature of performing serial invasive electrophysiologic studies However modern pacemakers now permit rapid non-invasive electrophysiologic testing and can also accurately document AHRE which allows the convenient study of therapy aimed at preventing the progression from AHRE to overt AF In addition this group of patients also affords the ability to evaluate the recurrence of AHRE on the progression of structural and electrical remodeling
Comparison Irbesartan compared to placebo
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 |
|---|---|---|---|
| CTA-099104 | None | None | None |