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

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ClinicalTrials.gov Identifier: NCT01461733

Recruitment Status : Completed

First Posted : October 28, 2011

Results First Posted : September 15, 2014

Last Update Posted : September 15, 2014

Sponsor:

Collaborator:

Heart and Stroke Foundation of Ontario

Information provided by (Responsible Party):

S. Kanji, Ottawa Hospital Research Institute

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Atrial Fibrillation	Drug: amiodarone Drug: Placebo	Phase 4

Detailed Description:

see above

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	25 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Atrial Fibrillation WITHOUT Hemodynamic Stability
Study Start Date :	July 2007
Actual Primary Completion Date :	June 2009
Actual Study Completion Date :	December 2009

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Drug Information available for: Amiodarone Amiodarone hydrochloride

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: amiodarone standard dose amiodarone	Drug: amiodarone standard dose amiodarone Other Name: non applicable
Placebo Comparator: placebo	Drug: Placebo placebo delivered blinded

Outcome Measures

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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

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Principal Investigator:	Salmaan Kanji, MD	Ottawa Hospital Research Institute

More Information

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Responsible Party:	S. Kanji, MD, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:	NCT01461733
Other Study ID Numbers:	NA5936 Heart and Stroke OHREB Protocol # 2006430-01 ( Other Grant/Funding Number: heart and stroke foundation of ON )
First Posted:	October 28, 2011 Key Record Dates
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:

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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

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