Candesartan in the Prevention of Relapsing Atrial Fibrillation
Information source: Asker & Baerum Hospital
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Atrial Fibrillation
Intervention: Candesartan (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Asker & Baerum Hospital Official(s) and/or principal investigator(s):
Arnljot Tveit, MD, Principal Investigator, Affiliation: Asker & Baerum Hospital
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Recurrence of atrial fibrillation
Secondary outcome: Time to recurrence of atrial fibrillation
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with atrial fibrillation, diagnosed electrocardiographically, of more than 48
hours duration in whom direct current (DC) cardioversion is planned.
Exclusion Criteria:
- Patients with a history of known hypersensitivity or contraindication to any
angiotensin II receptor blocker or any angiotensin-converting enzyme (ACE) inhibitor.
- Patients currently receiving an ACE inhibitor or angiotensin II antagonist because of
heart failure or other strong indication.
- Patients currently receiving any antiarrhythmic medication including sotalol. Other
beta-blockers will not be regarded as specific antiarrhythmic agents.
- Significant renal artery stenosis and any medical condition in which administration of
a vasodilator is contraindicated; serum creatinine > 225 micromol/L; or serum
potassium > 5. 5 mmol/L; or serum sodium < 128 mmol/L.
- Patients with severe hepatic dysfunction.
- Life-limiting disease or substance abuse which may affect participation.
- Patients unwilling to participate.
- Patients who have previously undergone DC cardioversion for atrial fibrillation within
the last month.
- Thyrotoxicosis.
- Patients with a systolic blood pressure of < 100 mm Hg.
- Hypertensive patients requiring intensified treatment prior to DC cardioversion.
- Pregnancy or lactation.
Locations and Contacts
Asker & Baerum Hospital, Rud 1309, Norway
Ulleval University Hospital, Oslo 0407, Norway
Additional Information
Starting date: April 2001
Ending date: September 2005
Last updated: January 3, 2007
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