Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00130975
Status:
COMPLETED
Last Update Posted:
2007-01-04
First Post:
2005-08-16
Brief Title:
Candesartan in the Prevention of Relapsing Atrial Fibrillation
Sponsor:
Asker Baerum Hospital
Organization:
Asker Baerum Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-01
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 test the hypothesis that treatment with the angiotensin II type 1 receptor antagonist candesartan may reduce the recurrence rate of atrial fibrillation after electrical cardioversion
Detailed Description:
Background The most effective procedure to restore sinus rhythm in patients with persistent atrial fibrillation AF is electrical cardioversion but AF recurs in 60-80 of the patients during the first year AF is associated with electrical and anatomical remodelling of the atria and angiotensin II is involved in the remodelling process Studies have indicated that the angiotensin II type 1 receptor antagonist candesartan may counteract both electrical and anatomical remodelling induced by AF The investigators therefore hypothesised that treatment with candesartan may reduce the recurrence rate of AF after electrical cardioversion
Study design 171 patients with persistent AF scheduled for electrical cardioversion are randomised in a double blind placebo-controlled study The patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion The study medication is discontinued if electrical cardioversion is unsuccessful or if AF recurrence is documented Primary endpoint is recurrence of AF Clinical electrocardiographic echocardiographic and biochemical markers will be analysed
Study design 171 patients with persistent AF scheduled for electrical cardioversion are randomised in a double blind placebo-controlled study The patients receive tablets of candesartan 8 mg or matching placebo once daily for 3-6 weeks before cardioversion and candesartan 16 mg or matching placebo once daily for 6 months after cardioversion The study medication is discontinued if electrical cardioversion is unsuccessful or if AF recurrence is documented Primary endpoint is recurrence of AF Clinical electrocardiographic echocardiographic and biochemical markers will be analysed
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