Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Trial ID or NCT#
NCT01970501
Status
NOT RECRUITING
Purpose
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.
Official Title
GENETIC-AF - A Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Symptomatic Atrial Fibrillation/Atrial Flutter in Patients With Heart Failure
Eligibility Criteria
Ages Eligible for Study: 18 Years to 85 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - Must weigh at least 40 kg - Possess the β1389 Arg/Arg genotype - Left Ventricular Ejection Fraction (LVEF) < 0.50 assessed within 12 months prior to Screening - At least one episode of symptomatic paroxysmal or persistent AF within 180 days of Screening - Clinically appropriate for electrical cardioversion (ECV) if AF/AFL is present after study drug initiation - Receiving appropriate anticoagulation therapy prior to Randomization Key
Exclusion Criteria:
- - NYHA Class IV symptoms at the time of Randomization - Significant fluid overload at Randomization - Permanent AF at Screening - More than two previous ECV within 6 months of Randomization or if the most recent ECV failed to produce SR - Presence of an LVAD, or likely to requirement LVAD placement within 6 months of Randomization - History of a successful atrioventricular (AV) node ablation - History of an AF/AFL ablation within 30 days of Randomization - Evidence of an appropriate firing of an implanted cardioverter-defibrillator (ICD) device for ventricular tachycardia (VT) or ventricular fibrillation (VF) within 90 days of Randomization