Candesartan in the Prevention of Relapsing Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00130975
• Other study ID #: CAPRAF
• Status: Completed
• Phase: Phase 3
• First received: August 16, 2005
• Last updated: January 3, 2007
• Start date: April 2001
• Est. completion date: September 2005

Study information

• Verified date: January 2007
• Source: Asker & Baerum Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Candesartan

Locations

Country	Name	City	State
Norway	Ulleval University Hospital	Oslo
Norway	Asker & Baerum Hospital	Rud

Sponsors (4)

Lead Sponsor	Collaborator
Asker & Baerum Hospital	AstraZeneca, Helse Ost, Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Tveit A, Grundvold I, Olufsen M, Seljeflot I, Abdelnoor M, Arnesen H, Smith P. Candesartan in the prevention of relapsing atrial fibrillation. Int J Cardiol. 2007 Aug 9;120(1):85-91. Epub 2006 Nov 17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial fibrillation
Secondary	Time to recurrence of atrial fibrillation