This study is being done to compare the effects of bucindolol hydrochloride (bucindolol) to metoprolol succinate (Toprol-XL) on the recurrence of symptomatic atrial fibrillation/atrial flutter in patients with heart failure who have a specific genotype for the beta-1 adrenergic receptor.
The goal of the GENETIC-AF trial is to demonstrate the superiority of pharmacogenetically targeted bucindolol compared to metoprolol for the prevention of symptomatic atrial fibrillation or atrial flutter in a genotype-defined population with heart failure and/or reduced left ventricular ejection fraction at high risk of atrial fibrillation/atrial flutter recurrence.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
267
Time to First Event of Symptomatic Atrial Fibrillation/Atrial Flutter (AF/AFL) or All Cause Mortality (ACM) During the 24-week Follow-up Period After Establishment of Stable Sinus Rhythm (SR) on Study Drug [End of Treatment Week 24].
Time-to-event is calculated as the date of the event minus the date of initiation of efficacy follow-up, with 1 added in order to include both the start date and end date of the interval. Cox's proportional hazards model will be used to calculate estimated hazard ratios and 95% confidence intervals. The calculations will be performed with the SAS PHREG procedure, with the stratification variables specified in the STRATA statement and the treatment group comparator and any covariates being examined specified in the MODEL statement. For the primary endpoint, the appropriateness of assuming proportional hazards will be explored by the graphing of log (-log(survival function)) over follow-up for each treatment group.
Time frame: end of treatment week 24
Time to First Event of Symptomatic or Asymptomatic AF/AFL or ACM During the 24-week Follow-up Period After Establishment of Stable SR on Study Drug [End of Treatment Week 24]
Number of days on study medication before participant experienced symptomatic or asymptomatic atrial fibrillation, atrial flutter, or all-cause mortality during the 24 week follow up period.
Time frame: end of treatment week 24
Number of Patients With Adequate Ventricular Rate Control During the 24-week Follow-up Period
Number of patients with adequate ventricular rate control following the start of medication during the 24-week Follow-up Period
Time frame: end of treatment week 24
Total Number of Hospitalization Days Per Patient (All-cause) During the Total Study Period (24 Weeks)
Total number of hospitalization days per patient (all-cause) following the start of study medication during the Total Study Period (24 weeks). Hospitalization was defined by a hospital admission (note that same day admit and discharge equates to 0 days duration), ER visits were not counted as events.
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ARCA Clinical Research Site #157
Anchorage, Alaska, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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East Palo Alto, California, United States
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Loma Linda, California, United States
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Pasadena, California, United States
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Stanford, California, United States
ARCA Clinical Research Site #153
Aurora, Colorado, United States
ARCA Clinical Research Site #380
Denver, Colorado, United States
ARCA Clinical Research Site #195
Miami, Florida, United States
...and 87 more locations
Time frame: 24 weeks