NCT00392431

Brief Summary

Our hypothesis is that episodic amiodarone treatment (i.e. amiodarone treatment 1 month prior until 1 month after cardioversion) is associated with a lower morbidity and a higher quality of life compared to continuous prophylactic amiodarone treatment while atrial fibrillation is still effectively suppressed. The latter means that at the end of the study permanent atrial fibrillation is prevented in comparable percentage of patients (70%) in both treatment strategies. However, this will be accomplished at the cost of a higher number of electrical cardioversions (2-3) in the episodic treatment group compared to the continuous treatment group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2003

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

March 22, 2007

Status Verified

March 1, 2007

First QC Date

October 25, 2006

Last Update Submit

March 21, 2007

Conditions

Persistant Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Adverse events related to amiodarone use and/or atrial fibrillation itself or underlying heart disease

Secondary Outcomes (2)

  • Quality of life

  • Number of patients with permanent AF at the end of the study

Interventions

amiodaroneDRUG

Eligibility Criteria

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

You may qualify if:

  • Symptomatic persistent atrial fibrillation for at least 48 hours- 1 year (present episode).
  • Older than 18 years of age.
  • Ventricular rate during AF \> 75 beats per minute, documented on rest-ECG without rate control.
  • At least two weeks of oral anticoagulation therapy before screening.
  • Written informed consent.

You may not qualify if:

  • Contra indications for amiodarone (severe chronic obstructive pulmonary disease or QTc \> 440ms).
  • History of relapse of AF during adequate amiodarone treatment (i.e. adequate amiodarone and desethylamiodarone plasma levels).
  • Concomitant treatment with class I or III antiarrhythmic drugs. Amiodarone should not have been used during the last 3 months.
  • Other (non) cardiac QT prolonging drugs (if not possible to discontinue).
  • First episode of persistent atrial fibrillation.
  • More than three relapses of persistent atrial fibrillation necessitating electrical cardioversion during the last three years.
  • Known sick sinus syndrome.
  • History of second or third degree AV conduction disturbances.
  • Intraventricular conduction disturbances (QRS\> 140ms).
  • Pacemaker treatment.
  • Hemodynamically significant valvular disease.
  • Patients with heart failure with symptoms according to NYHA class III or IV.
  • Unstable angina pectoris.
  • Recent myocardial infarction (\< 3 months).
  • PTCA, CABG, other cardiac surgery or major non-cardiac surgery within the last three months.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

Related Publications (2)

  • Ahmed S, Ranchor AV, Crijns HJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT investigators. Effect of continuous versus episodic amiodarone treatment on quality of life in persistent atrial fibrillation. Europace. 2010 Jun;12(6):785-91. doi: 10.1093/europace/euq049. Epub 2010 Mar 2.

    PMID: 20200016DERIVED

  • Ahmed S, Rienstra M, Crijns HJ, Links TP, Wiesfeld AC, Hillege HL, Bosker HA, Lok DJ, Van Veldhuisen DJ, Van Gelder IC; CONVERT Investigators. Continuous vs episodic prophylactic treatment with amiodarone for the prevention of atrial fibrillation: a randomized trial. JAMA. 2008 Oct 15;300(15):1784-92. doi: 10.1001/jama.300.15.1784.

    PMID: 18854540DERIVED

MeSH Terms

Interventions

Amiodarone

Intervention Hierarchy (Ancestors)

BenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Isabelle C Van Gelder, MD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 25, 2006

First Posted

October 26, 2006

Study Start

January 1, 2003

Study Completion

March 1, 2007

Last Updated

March 22, 2007

Record last verified: 2007-03

Locations

NL(1)