Continuous Versus Episodic Amiodarone Treatment for the Prevention of Permanent Atrial Fibrillation - Full Text View

Sponsors and Collaborators:	University Medical Centre Groningen Netherlands Heart Foundation
Information provided by:	University Medical Centre Groningen
ClinicalTrials.gov Identifier:	NCT00392431

Purpose

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.

Condition	Intervention
Persistant Atrial Fibrillation	Drug: amiodarone

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Amiodarone hydrochloride Amidox Amiodarone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by University Medical Centre Groningen:

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

Estimated Enrollment:	220
Study Start Date:	January 2003
Study Completion Date:	March 2007

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392431

Locations

Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB

Sponsors and Collaborators

University Medical Centre Groningen

Netherlands Heart Foundation

Investigators

Principal Investigator:

Isabelle C Van Gelder, MD

University Medical Centre Groningen

More Information

No publications provided by University Medical Centre Groningen

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	2000B133
Study First Received:	October 25, 2006
Last Updated:	March 21, 2007
ClinicalTrials.gov Identifier:	NCT00392431 History of Changes
Health Authority:	European Union: European Medicines Agency

Study placed in the following topic categories:

Vasodilator Agents
Heart Diseases
Quality of Life
Cardiovascular Agents

Anti-Arrhythmia Agents
Atrial Fibrillation
Amiodarone
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Vasodilator Agents
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Cardiovascular Agents
Amiodarone
Pharmacologic Actions

Pathologic Processes
Therapeutic Uses
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009