NCT00784316

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P50-P75 for phase_4 atrial-fibrillation

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_4 atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 3, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 24, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

October 31, 2008

Last Update Submit

November 23, 2011

Conditions

Atrial FibrillationCardiac Surgery

Keywords

Prevention

Outcome Measures

Primary Outcomes (1)

  • Incidence of atrial fibrillation

    48 hours

Study Arms (2)

metoprolol

ACTIVE COMPARATOR
Drug: metoprolol, amiodarone

amiodarone

ACTIVE COMPARATOR
Drug: metoprolol, amiodarone

Interventions

metoprolol, amiodaroneDRUG

to compare the effectiviness of intravenous administration of metoprolol and amiodarone in the prevention of atrial fibrillation after cardiac surgery

amiodaronemetoprolol

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Halonen jari

Kuopio, FIN- 70211, Finland

Location

Related Publications (1)

  • 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.

    PMID: 21135293DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

MetoprololAmiodarone

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

October 31, 2008

First Posted

November 3, 2008

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 24, 2011

Record last verified: 2011-11

Locations

FI(1)