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Candesartan in the Prevention of Relapsing Atrial Fibrillation - Article


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Candesartan

Atacand; candesartan cilexetil 




Clinical Trial: Candesartan in the Prevention of Relapsing Atrial Fibrillation

This study is no longer recruiting patients.

Sponsors and Collaborators: Asker & Baerum Hospital
Helse Ost
Ullevaal University Hospital
AstraZeneca
Information provided by: Asker & Baerum Hospital
ClinicalTrials.gov Identifier: NCT00130975

Purpose

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.
Condition Intervention Phase
Atrial Fibrillation
 Drug: Candesartan
Phase III

MedlinePlus related topics:  Arrhythmia

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Further Study Details: 
Primary Outcomes: Recurrence of atrial fibrillation.
Secondary Outcomes: Time to recurrence of atrial fibrillation.
Expected Total Enrollment:  200

Study start: April 2001;  Study completion: October 2005
Last follow-up: September 2005;  Data entry closure: September 2005

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. We 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

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • Patients with atrial fibrillation diagnosed electrocardiographically of more than 48 hours duration in whom DC cardioversion is planned.

Exclusion Criteria:

  • Patients with a history of known hypersensitivity or contraindication to any angiotensin II receptor blocker or any 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.

Location Information


Norway
      Asker & Baerum Hospital, Rud,  1309,  Norway

      Ulleval University Hospital, Oslo,  0407,  Norway

Study chairs or principal investigators

Arnljot Tveit, MD,  Principal Investigator,  Asker & Baerum Hospital   

More Information

Study ID Numbers:  CAPRAF
Last Updated:  August 16, 2005
Record first received:  August 16, 2005
ClinicalTrials.gov Identifier:  NCT00130975
Health Authority: Norway: Norwegian Medicines Agency
ClinicalTrials.gov processed this record on 2005-08-23

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November 23, 2009



Page Updated: September 6, 2005
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