Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Status: | Completed |
---|---|
Conditions: | Atrial Fibrillation, Atrial Fibrillation, Cardiology |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 12/5/2018 |
Start Date: | April 2014 |
End Date: | December 28, 2017 |
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
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.
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.
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.
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
We found this trial at
48
sites
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