Heart Failure Clinical Trial
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
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.
Full Description
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.
Eligibility 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
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There are 96 Locations for this study
Anchorage Alaska, 99508, United States
Phoenix Arizona, 85004, United States
Phoenix Arizona, 85018, United States
East Palo Alto California, 94303, United States
Loma Linda California, 92357, United States
Pasadena California, 91105, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80120, United States
Miami Florida, 33136, United States
Tampa Florida, 33606, United States
Athens Georgia, 30606, United States
Atlanta Georgia, 30322, United States
Oakbrook Terrace Illinois, 60181, United States
Hammond Indiana, 46320, United States
Iowa City Iowa, 52242, United States
New Orleans Louisiana, 70121, United States
Baltimore Maryland, 21287, United States
Ypsilanti Michigan, 48197, United States
Minneapolis Minnesota, 55417, United States
Saint Paul Minnesota, 55102, United States
Saint Louis Missouri, 63110, United States
Saint Louis Missouri, 63128, United States
Lincoln Nebraska, 68506, United States
Elmer New Jersey, 08318, United States
Hillsborough New Jersey, 08844, United States
Albany New York, 12205, United States
New York New York, 10029, United States
Durham North Carolina, 27705, United States
Greensboro North Carolina, 27401, United States
Akron Ohio, 44304, United States
Cincinnati Ohio, 45219, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43210, United States
Oklahoma City Oklahoma, 73135, United States
Portland Oregon, 97201, United States
Hershey Pennsylvania, 17033, United States
Lancaster Pennsylvania, 17603, United States
Philadelphia Pennsylvania, 19104, United States
Germantown Tennessee, 38138, United States
Jackson Tennessee, 38305, United States
Dallas Texas, 75230, United States
Salt Lake City Utah, 84132, United States
Charlottesville Virginia, 22908, United States
Falls Church Virginia, 22042, United States
Manassas Virginia, 20109, United States
Norfolk Virginia, 23507, United States
Puyallup Washington, 98372, United States
Calgary Alberta, T2N 4, Canada
Vancouver British Columbia, V6E 1, Canada
Cambridge Ontario, N1R 6, Canada
Cambridge Ontario, N1R 7, Canada
Hamilton Ontario, L8L 2, Canada
London Ontario, N6A 5, Canada
Newmarket Ontario, L3Y 2, Canada
Oshawa Ontario, L1H 1, Canada
Ottawa Ontario, K1Y 4, Canada
Toronto Ontario, M4N 3, Canada
Waterloo Ontario, N2J 1, Canada
Montreal Quebec, H1T 1, Canada
Montreal Quebec, H2W 1, Canada
Montreal Quebec, H3G 1, Canada
Saint-Jerome Quebec, J7Z 5, Canada
Sherbrooke Quebec, J1H 5, Canada
Trois-Rivières Quebec, G8Z 3, Canada
Quebec , G1V 4, Canada
Budapest , 1096, Hungary
Budapest , 1122, Hungary
Budapest , 1134, Hungary
Budapest , 1145, Hungary
Debrecen , 4032, Hungary
Kaposvar , 7400, Hungary
Pecs , 7624, Hungary
Szeged , 6725, Hungary
Szolnok , 5000, Hungary
Capelle aan den IJssel , 2906 , Netherlands
Gorinchem , 4204 , Netherlands
Groningen , 9713 , Netherlands
Helmond , 5707 , Netherlands
Leiderdorp , 2334 , Netherlands
Roosendaal , 4708 , Netherlands
Sneek , 8601 , Netherlands
Stadskanaal , 9501 , Netherlands
Tiel , 4002 , Netherlands
Bialystok , 15-27, Poland
Gdansk , 80-95, Poland
Krakow , 31-50, Poland
Lodz , 91-34, Poland
Lodz , 92-21, Poland
Lublin , 20-95, Poland
Warsaw , 02-09, Poland
Wroclaw , 50-98, Poland
Belgrade , 11000, Serbia
Belgrade , 11080, Serbia
Kragujevac , 34000, Serbia
Niš , 18000, Serbia
Niš , 18000, Serbia
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