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Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation

Primary Purpose

Persistant Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

amiodarone

About this trial

This is an interventional treatment trial for Persistant Atrial Fibrillation

Eligibility Criteria

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

Inclusion criteria:

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.

Exclusion criteria:

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.
History of hyperthyroidism or hypothyroidism.
Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease.
Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception.
Treatment with any other investigational agent.
Presence of any disease that is likely to shorten life expectancy to < 1 year.
Any condition that in the opinion of the investigator would jeopardise the evaluation of efficacy or safety or be associated with poor adherence to the protocol.

Sites / Locations

University Medical Center Groningen

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life

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

Full Information

NCT ID

NCT00392431

First Posted

October 25, 2006

Last Updated

March 21, 2007

Sponsor

University Medical Center Groningen

Collaborators

Netherlands Heart Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00392431

Brief Title

Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation

Official Title

Continuous Versus Episodic Prophylactic Treatment With Oral Amiodarone for the Prevention of Permanent Atrial Fibrillation: a Randomized Study on Morbidity and Quality of Life

Study Type

Interventional

2. Study Status

Record Verification Date

March 2007

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Medical Center Groningen

Collaborators

Netherlands Heart Foundation

4. Oversight

5. Study Description

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.

Detailed Description

Primary objective To determine differences in adverse event rates between patients with persistent atrial fibrillation who are randomized to episodic amiodarone treatment (EAT) strategy and patients who are randomized to continuous amiodarone treatment (CAT) strategy, while atrial fibrillation is still effectively suppressed. Adverse events can be related to: amiodarone use atrial fibrillation itself or underlying heart disease. Secondary objective To determine differences in quality of life between patients with persistent atrial fibrillation who are randomized to the EAT strategy and patients who are randomized to the CAT strategy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Persistant Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

220 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

amiodarone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Quality of life

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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. History of hyperthyroidism or hypothyroidism. Serious pulmonary, hepatic, haematological, metabolic, renal, gastrointestinal, CNS or psychiatric disease. Pregnant and non-pregnant women who are pre-menopausal and are not practising an acceptable method of contraception. Treatment with any other investigational agent. Presence of any disease that is likely to shorten life expectancy to < 1 year. Any condition that in the opinion of the investigator would jeopardise the evaluation of efficacy or safety or be associated with poor adherence to the protocol.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Isabelle C Van Gelder, MD

Organizational Affiliation

University Medical Center Groningen

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Groningen

City

Groningen

ZIP/Postal Code

9700RB

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

20200016

Citation

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.

Results Reference

derived

PubMed Identifier

18854540

Citation

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.

Results Reference

derived

Learn more about this trial

Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation

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