Comparing the Effects of Amiodarone, Sotalol, and Placebo in Maintaining Sinus Rhythm in Patients With Atrial Fibrillation Converted to Sinus Rhythm

This study has been completed.

First Received: December 29, 2000 Last Updated: January 20, 2009 History of Changes

Sponsor:	Department of Veterans Affairs
Information provided by:	Department of Veterans Affairs
ClinicalTrials.gov Identifier:	NCT00007605

Purpose

Atrial fibrillation is the most frequently occurring cardiac arrhythmia, with 1.0-1.5 million cases annually. It is a risk factor for congestive heart failure, and stroke, 75,000 cases of the latter occurring annually in patients with atrial fibrillation. The safety of the most widely used antiarrhythmic agent for this group of patients, quinidine, has been called into question. This study seeks to determine whether two other agents, amiodarone and sotalol, are safe and effective treatments for patients with atrial fibrillation.

Condition	Intervention	Phase
Atrial Fibrillation Cerebrovascular Accident Death, Sudden	Drug: Amiodarone Drug: Sotalol	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	The Effects of Antiarrhythmic Therapy in Maintaining Stability of Sinus Rhythm in Atrial Fibrillation

Resource links provided by NLM:

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 Sotalol hydrochloride Amiodarone Sotalol

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment:	706
Study Start Date:	April 1998
Estimated Study Completion Date:	September 2002

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Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Patients who have atrial fibrillation continuously for greater than 72 hours.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007605

Show 33 Study Locations

Sponsors and Collaborators

Department of Veterans Affairs

More Information

No publications provided

Study ID Numbers:	399
Study First Received:	December 29, 2000
Last Updated:	January 20, 2009
ClinicalTrials.gov Identifier:	NCT00007605 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:

sinus rhythm
amiodarone
sotalol

atrial fibrillation converted to sinus rhythm
major and minor bleeds
cardiac mortality

Additional relevant MeSH terms:

Neurotransmitter Agents
Death
Vasodilator Agents
Adrenergic Agents
Cerebral Infarction
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Brain Diseases
Cerebrovascular Disorders
Pathologic Processes
Therapeutic Uses
Adrenergic beta-Antagonists
Brain Ischemia
Cardiovascular Diseases
Anti-Arrhythmia Agents

Sympatholytics
Heart Diseases
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents
Amiodarone
Pharmacologic Actions
Sotalol
Autonomic Agents
Death, Sudden
Adrenergic Antagonists
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010