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

This study is currently recruiting participants.

Verified by Kuopio University Hospital, August 2009

First Received: October 31, 2008 Last Updated: August 10, 2009 History of Changes

Sponsor:	Kuopio University Hospital
Collaborators:	Heart Center, Tampere, Finland Vaasa Central Hospital, Vaasa, Finland North-Carelia Central Hospital, Joensuu, Finland
Information provided by:	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:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 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 ]

Estimated Enrollment:	316
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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

Contacts

Contact: Jari Halonen, MD

+358405885829

jari.halonen@kuh.fi

Locations

Finland
Halonen jari	Recruiting
Kuopio, Finland, FIN- 70211
Contact: Jari Halonen, MD +358405885829 jari.halonen@kuh.fi

Sponsors and Collaborators

Kuopio University Hospital

Heart Center, Tampere, Finland

Vaasa Central Hospital, Vaasa, Finland

North-Carelia Central Hospital, Joensuu, Finland

More Information

No publications provided

Responsible Party:	Kuopio University Hospital ( Halonen Jari MD, Kuopio University Hospital )
Study ID Numbers:	KUH5204005
Study First Received:	October 31, 2008
Last Updated:	August 10, 2009
ClinicalTrials.gov Identifier:	NCT00784316 History of Changes
Health Authority:	Finland: Research Ethics Committee, Hospital District of Northern Savo

Keywords provided by Kuopio University Hospital:

Prevention

Additional relevant MeSH terms:

Sympatholytics
Neurotransmitter Agents
Vasodilator Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Metoprolol
Amiodarone

Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Metoprolol succinate
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Peripheral Nervous System Agents
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010