search
Back to results

Candesartan in the Prevention of Relapsing Atrial Fibrillation

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Candesartan
Sponsored by
Asker & Baerum Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial fibrillation., Cardioversion., Recurrence., Candesartan.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ulleval University Hospital
  • Asker & Baerum Hospital

Outcomes

Primary Outcome Measures

Recurrence of atrial fibrillation

Secondary Outcome Measures

Time to recurrence of atrial fibrillation

Full Information

First Posted
August 16, 2005
Last Updated
January 3, 2007
Sponsor
Asker & Baerum Hospital
Collaborators
Helse Ost, Ullevaal University Hospital, AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00130975
Brief Title
Candesartan in the Prevention of Relapsing Atrial Fibrillation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Asker & Baerum Hospital
Collaborators
Helse Ost, Ullevaal University Hospital, AstraZeneca

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atrial fibrillation., Cardioversion., Recurrence., Candesartan.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Candesartan
Primary Outcome Measure Information:
Title
Recurrence of atrial fibrillation
Secondary Outcome Measure Information:
Title
Time to recurrence of atrial fibrillation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arnljot Tveit, MD
Organizational Affiliation
Asker & Baerum Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0407
Country
Norway
Facility Name
Asker & Baerum Hospital
City
Rud
ZIP/Postal Code
1309
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
17113170
Citation
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. doi: 10.1016/j.ijcard.2006.08.086. Epub 2006 Nov 17.
Results Reference
result
PubMed Identifier
29299030
Citation
Horjen AW, Seljeflot I, Berge T, Smith P, Arnesen H, Tveit A. Effect of sinus rhythm restoration on markers of thrombin generation in atrial fibrillation. Thromb J. 2017 Dec 28;15:30. doi: 10.1186/s12959-017-0153-1. eCollection 2017.
Results Reference
derived

Learn more about this trial

Candesartan in the Prevention of Relapsing Atrial Fibrillation

We'll reach out to this number within 24 hrs