@entity2399 versus placebo for XXXX : a randomized clinical trial.

@entity1 @entity2399 @entity341 @entity2400 @entity955
OBJECTIVES: The objective was to investigate the efficacy of @entity2399 ( @entity2400 ) in decreasing the ventricular rate in @entity341 ( @entity341 ) @entity1 presenting with new-onset, rapid @entity955 ( @entity955 ). METHODS: A double-blinded, placebo-controlled randomized clinical trial was conducted in an adult university hospital. @entity1 aged > or =18 years with @entity955 onset of less than 48 hours and a sustained ventricular rate of >100 beats/min were randomized to either intravenous (IV) @entity2400 10 mmol or normal saline (NSal). Rhythm and instantaneous heart rate as measured by the monitor were recorded at baseline and every 15 minutes for 2 hours after starting the trial drug. Heart rate and rhythm were compared at 2 hours. A multilevel modeling analysis was performed to adjust for differences in baseline heart rate and any additional treatment and to examine changes in heart rate over time. RESULTS: Twenty-four @entity1 were randomized to @entity2400 and 24 to NSal. Baseline heart rate was lower in the @entity2400 group (mean +/- standard deviation [+/-SD] = 125 +/- 24 vs. 140 +/- 21 beats/min]. One and 3 @entity1 in the @entity2400 and NSal groups, respectively, were given another antiarrhythmic or were electrically cardioverted within 2 hours after starting the trial drug. Heart rate (mean +/- SD) at 2 hours in both @entity2400 (116 +/- 30 beats/min) and NSal groups (114 +/- 31 beats/min) decreased below their respective baseline levels. However, the rate of heart rate decrease across time did not differ between groups (p = 0.124). The proportion of @entity1 who converted to sinus rhythm 2 hours post-trial drug did not differ ( @entity2400 8.7% vs. NSal 25.0%, p = 0.25). CONCLUSIONS: This study was unable to demonstrate a difference between IV @entity2400 10 mmol and saline placebo for reducing heart rate or conversion to sinus rhythm at 2 hours posttreatment in @entity341 @entity1 with @entity955 of less than 48 hours duration.
