Education and Training

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

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.

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: bucindolol hydrochloride
  • drug: metoprolol succinate
  • other: Placebo oral capsule

Eligibility


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

Ages Eligible for Study

18 Years - 85 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting