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Candesartan in the Prevention of Relapsing Atrial Fibrillation

This study has been completed.
Sponsor:
Collaborators:
Helse Ost
Ullevaal University Hospital
AstraZeneca
Information provided by:
Asker & Baerum Hospital
ClinicalTrials.gov Identifier:
NCT00130975
First received: August 16, 2005
Last updated: January 3, 2007
Last verified: January 2007
History of Changes
  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 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Asker & Baerum Hospital:

Primary Outcome Measures:
  • Recurrence of atrial fibrillation

Secondary Outcome Measures:
  • Time to recurrence of atrial fibrillation

Estimated Enrollment: 200
Study Start Date: April 2001
Estimated Study Completion Date: September 2005
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00130975

Locations
Norway
Ulleval University Hospital
Oslo, Norway, 0407
Asker & Baerum Hospital
Rud, Norway, 1309
Sponsors and Collaborators
Asker & Baerum Hospital
Helse Ost
Ullevaal University Hospital
AstraZeneca
Investigators
Principal Investigator: Arnljot Tveit, MD Asker & Baerum Hospital
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00130975     History of Changes
Other Study ID Numbers: CAPRAF
Study First Received: August 16, 2005
Last Updated: January 3, 2007
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Asker & Baerum Hospital:
Atrial fibrillation.
Cardioversion.
Recurrence.
Candesartan.

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Candesartan
Candesartan cilexetil
 Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 17, 2013