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Intravenous Administration of Metoprolol Versus Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery

This study has been completed.
Sponsor:
Collaborators:
Oulu University Hospital
Hospital Cordia, Kuopio, Finland
Information provided by (Responsible Party):
Jari Halonen, Kuopio University Hospital
ClinicalTrials.gov Identifier:
NCT00783900
First received: October 31, 2008
Last updated: November 23, 2011
Last verified: November 2011
History of Changes
  Purpose

The aim of the study is to compare the effectiviness of biatrial pacing versus intravenous administration of metoprolol in the prevention of atrial fibrillation after cardiac surgery


Condition Intervention Phase
Atrial Fibrillation
Biatrial Pacing
Metoprolol
 Other: metoprolol, biatrial pacing
 Phase 4

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 Biatrial Pacing in the Prevention of Atrial Fibrillation After Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kuopio University Hospital:

Primary Outcome Measures:
  • biatriac pacing [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Incidence of atrial fibrillation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 316
Study Start Date: January 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: metoprolol Other: metoprolol, biatrial pacing
Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol
Active Comparator: biatrial pacing Other: metoprolol, biatrial pacing
Prevention, atrial fibrillation, cardiac surgery, biatrial pacing, metoprolol

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective CABG and aortic valve cardiac patients,
  • previous use of beta blocker

Exclusion Criteria:

  • Previous episodes of Atrial fibrillation or flutter,
  • II or II degree atrioventricular block, uncontrolled heart failure
  • Sick sinus syndrome
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783900

Locations
Finland
Halonen Jari
Kuopio, Finland, FIN-70211
Sponsors and Collaborators
Kuopio University Hospital
Oulu University Hospital
Hospital Cordia, Kuopio, Finland
  More Information

No publications provided

Responsible Party: Jari Halonen, MD, PhD, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT00783900     History of Changes
Other Study ID Numbers: KUH5204006, Eudra-CT: 2008-006932-36
Study First Received: October 31, 2008
Last Updated: November 23, 2011
Health Authority: Finland: Finnish Medicines Agency
Finland: Researc 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
Metoprolol
Metoprolol succinate
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
 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
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013