NCT00130975

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3 atrial-fibrillation

Timeline
Completed

Started Apr 2001

Typical duration for phase_3 atrial-fibrillation

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2005

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
Last Updated

January 4, 2007

Status Verified

January 1, 2007

First QC Date

August 16, 2005

Last Update Submit

January 3, 2007

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation.Cardioversion.Recurrence.Candesartan.

Outcome Measures

Primary Outcomes (1)

  • Recurrence of atrial fibrillation

Secondary Outcomes (1)

  • Time to recurrence of atrial fibrillation

Interventions

CandesartanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ulleval University Hospital

Oslo, 0407, Norway

Location

Asker & Baerum Hospital

Rud, 1309, Norway

Location

Related Publications (2)

  • 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.

    PMID: 17113170RESULT

  • 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.

    PMID: 29299030DERIVED

MeSH Terms

Conditions

Atrial FibrillationRecurrence

Interventions

candesartan

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Arnljot Tveit, MD

    Asker & Baerum Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 17, 2005

Study Start

April 1, 2001

Study Completion

September 1, 2005

Last Updated

January 4, 2007

Record last verified: 2007-01

Locations

NO(2)