Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery

This study has been completed.

First Received on October 31, 2008. Last Updated on November 23, 2011 History of Changes

Sponsor:	Kuopio University Hospital
Collaborators:	Tampere University Hospital Vaasa Central Hospital, Vaasa, Finland
Information provided by (Responsible Party):	Jari Halonen, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00784316

Purpose

The aim of the study is to test the efficiency of intravenous administration of metoprolol versus intravenous administration of amiodarone in the prevention of atrial fibrillation after cardiac surgery.

Condition	Intervention	Phase
Atrial Fibrillation Cardiac Surgery	Drug: metoprolol, amiodarone	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery

Resource links provided by NLM:

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

MedlinePlus related topics: Atrial Fibrillation Heart Surgery

Drug Information available for: Amiodarone hydrochloride Metoprolol Metoprolol Tartrate Amidox Metoprolol succinate Metoprolol fumarate Amiodarone

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:

Incidence of atrial fibrillation [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Enrollment:	316
Study Start Date:	August 2007
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: metoprolol	Drug: metoprolol, amiodarone to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery
Active Comparator: amiodarone	Drug: metoprolol, amiodarone to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

elective CABG and aortic valve patients in cardiac surgery,
previous use of betablocker therapy

Exclusion Criteria:

previous atrial fibrillation or flutter,
thyroid disease,
uncontrolled heart failure,
II or III degree atrioventricular block

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00784316

Locations

Finland
Halonen jari
Kuopio, Finland, FIN- 70211

Sponsors and Collaborators

Kuopio University Hospital

Tampere University Hospital

Vaasa Central Hospital, Vaasa, Finland

More Information

No publications provided by Kuopio University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Halonen J, Loponen P, Järvinen O, Karjalainen J, Parviainen I, Halonen P, Magga J, Turpeinen A, Hippeläinen M, Hartikainen J, Hakala T. Metoprolol versus amiodarone in the prevention of atrial fibrillation after cardiac surgery: a randomized trial. Ann Intern Med. 2010 Dec 7;153(11):703-9.

Responsible Party:	Jari Halonen, MD,PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier:	NCT00784316 History of Changes
Other Study ID Numbers:	KUH5204005
Study First Received:	October 31, 2008
Last Updated:	November 23, 2011
Health Authority:	Finland: Research Ethics Committee, Hospital District of Northern Savo

Keywords provided by Kuopio University Hospital:

Prevention

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Antihypertensive Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012