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Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit (AFIB)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01461733
First Posted: October 28, 2011
Last Update Posted: September 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
S. Kanji, Ottawa Hospital Research Institute
  Purpose

Atrial fibrillation (AF) is an abnormal heart rhythm that is common among patients who are admitted to an intensive care unit (ICU) of a hospital. It is usually a transient occurrence that resolves as the patient recovers from their underlying condition. However, patients who develop AF can present with a very rapid heart rate that in some cases can put stress on the heart which can lead to life threatening heart attacks, low blood pressure or breathing problems. Not all patients with AF will have unstable heart function but those who have rapid heart rates can worsen quickly. The goals of treatment for AF with a rapid heart rate but no unstable heart function are two fold. Patients can be treated by controlling the heart rate and/or by attempting to convert the AF to a normal heart rhythm. The heart rate can be controlled by medication and the AF can be converted by either electrical cardioversion (an electric shock that jump-starts the heart) or medication. Currently it is unknown if the goal of treatment should be to simply control the heart rate and wait for the patient to spontaneously convert to a normal heart rhythm or convert the AF with medication for patients who only have the rapid heart rate.

The objective of this project is to conduct a pilot study to determine if it would be feasible to conduct a larger definitive trial that would answer the following question: Should the goal of treatment be to control the rapid heart rate or resolve the abnormal heart rhythm in patients with AF who have a rapid heart rate without unstable heart function.


Condition Intervention Phase
Atrial Fibrillation Drug: amiodarone Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Atrial Fibrillation WITHOUT Hemodynamic Stability

Resource links provided by NLM:


Further study details as provided by S. Kanji, Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Conversion From Atrial Fibrillation to Sinus Rhythm [ Time Frame: From randomization to conversion or ICU discharge up to 100 months. ]
    Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.


Enrollment: 25
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: amiodarone
standard dose amiodarone
Drug: amiodarone
standard dose amiodarone
Other Name: non applicable
Placebo Comparator: placebo Drug: Placebo
placebo delivered blinded

Detailed Description:
see above
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • new onset afib

Exclusion Criteria:

  • hemodynamically unstable
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01461733


Sponsors and Collaborators
Ottawa Hospital Research Institute
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Salmaan Kanji, MD Ottawa Hospital Research Institute
  More Information

Responsible Party: S. Kanji, MD, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01461733     History of Changes
Other Study ID Numbers: NA5936 Heart and Stroke
OHREB Protocol # 2006430-01 ( Other Grant/Funding Number: heart and stroke foundation of ON )
First Submitted: August 19, 2010
First Posted: October 28, 2011
Results First Submitted: September 9, 2014
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by S. Kanji, Ottawa Hospital Research Institute:
atrial fibrillation
amiodarone

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Amiodarone
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors