Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure

• Status: Completed
• Trial end date: 2017-12-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ARCA Biopharma, Inc.
• Collaborator: Medtronic
• Treatments: Bucindolol; Metoprolol

Criteria

Key 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