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

Primary Purpose

Atrial Fibrillation, Cardiac Surgery

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
metoprolol, amiodarone
Sponsored by
Kuopio University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Atrial Fibrillation focused on measuring Prevention

Eligibility Criteria

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

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

Sites / Locations

  • Halonen jari

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

metoprolol

amiodarone

Arm Description

Outcomes

Primary Outcome Measures

Incidence of atrial fibrillation

Secondary Outcome Measures

Full Information

First Posted
October 31, 2008
Last Updated
November 23, 2011
Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland
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1. Study Identification

Unique Protocol Identification Number
NCT00784316
Brief Title
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Official Title
Intravenous Metoprolol Versus Intravenous Amiodarone in the Prevention of Atrial Fibrillation After Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kuopio University Hospital
Collaborators
Tampere University Hospital, Vaasa Central Hospital, Vaasa, Finland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Cardiac Surgery
Keywords
Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
316 (Actual)

8. Arms, Groups, and Interventions

Arm Title
metoprolol
Arm Type
Active Comparator
Arm Title
amiodarone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metoprolol, amiodarone
Intervention Description
to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery
Primary Outcome Measure Information:
Title
Incidence of atrial fibrillation
Time Frame
48 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Halonen jari
City
Kuopio
ZIP/Postal Code
FIN- 70211
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
21135293
Citation
Halonen J, Loponen P, Jarvinen O, Karjalainen J, Parviainen I, Halonen P, Magga J, Turpeinen A, Hippelainen 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. doi: 10.7326/0003-4819-153-11-201012070-00003.
Results Reference
derived

Learn more about this trial

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

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