Atrial Fibrillation
Conditions
Keywords
atrial fibrillation, amiodarone
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
Interventions
DRUGamiodarone
standard dose amiodarone
DRUGPlacebo
placebo delivered blinded
Sponsors
Heart and Stroke Foundation of Ontario
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* new onset afib
Exclusion criteria
* hemodynamically unstable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversion From Atrial Fibrillation to Sinus Rhythm | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Amiodarone standard dose amiodarone
amiodarone: standard dose amiodarone | 12 |
| Placebo Placebo: placebo delivered blinded | 12 |
| Total | 24 |
Baseline characteristics
| Characteristic | Amiodarone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 17 | 61 years STANDARD_DEVIATION 17 | 65 years STANDARD_DEVIATION 17 |
| Region of Enrollment Canada | 12 participants | 12 participants | 24 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 10 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
Conversion From Atrial Fibrillation to Sinus Rhythm
Conversion rates measured during ICU stay only. Average duration of ICU stay is 7 days.
Time frame: From randomization to conversion or ICU discharge up to 100 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Amiodarone | Conversion From Atrial Fibrillation to Sinus Rhythm | 8 participants |
| Placebo | Conversion From Atrial Fibrillation to Sinus Rhythm | 5 participants |