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Clinical Trials/NCT01461733
NCT01461733
Completed
Phase 4

Atrial Fibrillation WITHOUT Hemodynamic Stability

Ottawa Hospital Research Institute0 sites25 target enrollmentJuly 2007

Overview

Phase
Phase 4
Intervention
amiodarone
Conditions
Atrial Fibrillation
Sponsor
Ottawa Hospital Research Institute
Enrollment
25
Primary Endpoint
Conversion From Atrial Fibrillation to Sinus Rhythm
Status
Completed
Last Updated
11 years ago

Overview

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.

Detailed Description

see above

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
December 2009
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

S. Kanji

MD

Ottawa Hospital Research Institute

Eligibility Criteria

Inclusion Criteria

  • new onset afib

Exclusion Criteria

  • hemodynamically unstable

Arms & Interventions

amiodarone

standard dose amiodarone

Intervention: amiodarone

placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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.

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