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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

267

Study ID:

NCT01970501

Recruitment Status:

Completed

Sponsor:

ARCA Biopharma, Inc.

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There are 96 Locations for this study

See Locations Near You

ARCA Clinical Research Site #157
Anchorage Alaska, 99508, United States
ARCA Clinical Research Site #383
Phoenix Arizona, 85004, United States
ARCA Clinical Research Site #385
Phoenix Arizona, 85018, United States
ARCA Clinical Research Site #381
East Palo Alto California, 94303, United States
ARCA Clinical Research Site #186
Loma Linda California, 92357, United States
ARCA Clinical Research Site #320
Pasadena California, 91105, United States
ARCA Clinical Research Site #390
Stanford California, 94305, United States
ARCA Clinical Research Site #153
Aurora Colorado, 80045, United States
ARCA Clinical Research Site #380
Denver Colorado, 80120, United States
ARCA Clinical Research Site #195
Miami Florida, 33136, United States
ARCA Clinical Research Site #184
Tampa Florida, 33606, United States
ARCA Clinical Research Site #351
Athens Georgia, 30606, United States
ARCA Clinical Research Site #389
Atlanta Georgia, 30322, United States
ARCA Clinical Research Site #342
Oakbrook Terrace Illinois, 60181, United States
ARCA Clinical Research Site #303
Hammond Indiana, 46320, United States
ARCA Clinical Research Site #388
Iowa City Iowa, 52242, United States
ARCA Clinical Site #396
New Orleans Louisiana, 70121, United States
ARCA Clinical Research Site #398
Baltimore Maryland, 21287, United States
ARCA Clinical Research Site #127
Ypsilanti Michigan, 48197, United States
ARCA Clinical Research Site #156
Minneapolis Minnesota, 55417, United States
ARCA Clinical Research Site #174
Saint Paul Minnesota, 55102, United States
ARCA Clinical Research Site #108
Saint Louis Missouri, 63110, United States
ARCA Clinical Research Site #201
Saint Louis Missouri, 63128, United States
ARCA Clinical Research Site #152
Lincoln Nebraska, 68506, United States
ARCA Clinical Research Site #161
Elmer New Jersey, 08318, United States
ARCA Clinical Research Site #202
Hillsborough New Jersey, 08844, United States
ARCA Clinical Research Site # 179
Albany New York, 12205, United States
ARCA Clinical Research Site #397
New York New York, 10029, United States
ARCA Clinical Research Site #181
Durham North Carolina, 27705, United States
ARCA Clinical Research Site #349
Greensboro North Carolina, 27401, United States
ARCA Clinical Research Site #173
Akron Ohio, 44304, United States
ARCA Clinical Research Site #392
Cincinnati Ohio, 45219, United States
ARCA Clinical Research Site #322
Cleveland Ohio, 44106, United States
ARCA Clinical Research Site #151
Columbus Ohio, 43210, United States
ARCA Clinical Research Site #399
Oklahoma City Oklahoma, 73135, United States
ARCA Clinical Research Site #115
Portland Oregon, 97201, United States
ARCA Clinical Research Site # 189
Hershey Pennsylvania, 17033, United States
ARCA Clinical Research Site #109
Lancaster Pennsylvania, 17603, United States
ARCA Clinical Research Site #133
Philadelphia Pennsylvania, 19104, United States
ARCA Clinical Site #393
Germantown Tennessee, 38138, United States
ARCA Clinical Research Site #198
Jackson Tennessee, 38305, United States
ARCA Clinical Research Site #387
Dallas Texas, 75230, United States
ARCA Clinical Research Site #379
Salt Lake City Utah, 84132, United States
ARCA Clinical Site #391
Charlottesville Virginia, 22908, United States
ARCA Clinical Research Site #386
Falls Church Virginia, 22042, United States
ARCA Clinical Research Site #200
Manassas Virginia, 20109, United States
ARCA Research Site #131
Norfolk Virginia, 23507, United States
ARCA Clinical Research Site #196
Puyallup Washington, 98372, United States
ARCA Clinical Research Site #612
Calgary Alberta, T2N 4, Canada
ARCA Clinical Research Site #624
Vancouver British Columbia, V6E 1, Canada
ARCA Clinical Research Site #611
Cambridge Ontario, N1R 6, Canada
ARCA Clinical Research Site #621
Cambridge Ontario, N1R 7, Canada
ARCA Clinical Research Site #601
Hamilton Ontario, L8L 2, Canada
ARCA Clinical Research Site #609
London Ontario, N6A 5, Canada
ARCA Clinical Research Site #623
Newmarket Ontario, L3Y 2, Canada
ARCA Clinical Research Site #618
Oshawa Ontario, L1H 1, Canada
ARCA Clinical Research Site #613
Ottawa Ontario, K1Y 4, Canada
ARCA Clinical Research Site #619
Toronto Ontario, M4N 3, Canada
ARCA Clinical Research Site #616
Waterloo Ontario, N2J 1, Canada
ARCA Clinical Research Site #614
Montreal Quebec, H1T 1, Canada
ARCA Clinical Research Site #607
Montreal Quebec, H2W 1, Canada
ARCA Clinical Research Site #603
Montreal Quebec, H3G 1, Canada
ARCA Clinical Research Site #625
Saint-Jerome Quebec, J7Z 5, Canada
ARCA Clinical Research Site #602
Sherbrooke Quebec, J1H 5, Canada
ARCA Clinical Research Site #626
Trois-Rivières Quebec, G8Z 3, Canada
ARCA Clinical Research Site #615
Quebec , G1V 4, Canada
ARCA Clinical Research Site #726
Budapest , 1096, Hungary
ARCA Clinical Research Site #727
Budapest , 1122, Hungary
ARCA Clinical Research Site #728
Budapest , 1134, Hungary
ARCA Clinical Research Site #729
Budapest , 1145, Hungary
ARCA Clinical Research Site #733
Debrecen , 4032, Hungary
ARCA Clinical Research Site #732
Kaposvar , 7400, Hungary
ARCA Clinical Research Site #730
Pecs , 7624, Hungary
ARCA Clinical Research Site #731
Szeged , 6725, Hungary
ARCA Clinical Research Site #734
Szolnok , 5000, Hungary
ARCA Clinical Research Site #781
Capelle aan den IJssel , 2906 , Netherlands
ARCA Clinical Research Site #779
Gorinchem , 4204 , Netherlands
ARCA Clinical Research Site #776
Groningen , 9713 , Netherlands
ARCA Clinical Research Site #780
Helmond , 5707 , Netherlands
ARCA Clinical Research Site #782
Leiderdorp , 2334 , Netherlands
ARCA Clinical Research Site #786
Roosendaal , 4708 , Netherlands
ARCA Clinical Research Site #777
Sneek , 8601 , Netherlands
ARCA Clinical Research Site #783
Stadskanaal , 9501 , Netherlands
ARCA Clinical Research Site #784
Tiel , 4002 , Netherlands
ARCA Clinical Research Site #752
Bialystok , 15-27, Poland
ARCA Clinical Research Site #757
Gdansk , 80-95, Poland
ARCA Clinical Research Site #753
Krakow , 31-50, Poland
ARCA Clinical Research Site #755
Lodz , 91-34, Poland
ARCA Clinical Research Site #751
Lodz , 92-21, Poland
ARCA Clinical Research Site #758
Lublin , 20-95, Poland
ARCA Clinical Research Site #754
Warsaw , 02-09, Poland
ARCA Clinical Research Site #756
Wroclaw , 50-98, Poland
ARCA Clinical Research Site #807
Belgrade , 11000, Serbia
ARCA Clinical Research Site #806
Belgrade , 11080, Serbia
ARCA Clinical Research Site #801
Kragujevac , 34000, Serbia
ARCA Clinical Research Site #804
Niš , 18000, Serbia
ARCA Clinical Research Site #805
Niš , 18000, Serbia

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

267

Study ID:

NCT01970501

Recruitment Status:

Completed

Sponsor:


ARCA Biopharma, Inc.

How clear is this clinincal trial information?

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