Candesartan in the Prevention of Relapsing Atrial Fibrillation

January 3, 2007 updated by: Asker & Baerum Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0407
        • Ullevål University Hospital
      • Rud, Norway, 1309
        • Asker & Baerum Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Recurrence of atrial fibrillation

Secondary Outcome Measures

Outcome Measure
Time to recurrence of atrial fibrillation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asker & Baerum Hospital

Collaborators

Ullevaal University Hospital
AstraZeneca
Helse Ost

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

August 16, 2005

First Submitted That Met QC Criteria

August 16, 2005

First Posted (Estimate)

August 17, 2005

Study Record Updates

Last Update Posted (Estimate)

January 4, 2007

Last Update Submitted That Met QC Criteria

January 3, 2007

Last Verified

January 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPRAF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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