Atrial Fibrillation Without Hemodynamic Instability in the Intensive Care Unit (AFIB)
|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.|
|ClinicalTrials.gov Identifier: NCT01461733|
Recruitment Status : Completed
First Posted : October 28, 2011
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Atrial Fibrillation WITHOUT Hemodynamic Stability|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||December 2009|
standard dose amiodarone
standard dose amiodarone
Other Name: non applicable
|Placebo Comparator: placebo||
placebo delivered blinded
- 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.
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
|Principal Investigator:||Salmaan Kanji, MD||Ottawa Hospital Research Institute|