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Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (GENETIC-AF)

Primary Purpose

Current or Recent History of Atrial Fibrillation

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
bucindolol hydrochloride
metoprolol succinate
Placebo oral capsule
Sponsored by
ARCA Biopharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Current or Recent History of Atrial Fibrillation focused on measuring atrial fibrillation, atrial flutter, heart failure, reduced left ventricle ejection fraction, electrical cardioversion, GENETIC-AF, Medtronic, bucindolol, pharmacogenetic, ARCA, Toprol, Toprol-XL, Metoprolol, Metoprolol succinate

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ARCA Clinical Research Site #157
  • ARCA Clinical Research Site #383
  • ARCA Clinical Research Site #385
  • ARCA Clinical Research Site #381
  • ARCA Clinical Research Site #186
  • ARCA Clinical Research Site #320
  • ARCA Clinical Research Site #390
  • ARCA Clinical Research Site #153
  • ARCA Clinical Research Site #380
  • ARCA Clinical Research Site #195
  • ARCA Clinical Research Site #184
  • ARCA Clinical Research Site #351
  • ARCA Clinical Research Site #389
  • ARCA Clinical Research Site #342
  • ARCA Clinical Research Site #303
  • ARCA Clinical Research Site #388
  • ARCA Clinical Site #396
  • ARCA Clinical Research Site #398
  • ARCA Clinical Research Site #127
  • ARCA Clinical Research Site #156
  • ARCA Clinical Research Site #174
  • ARCA Clinical Research Site #108
  • ARCA Clinical Research Site #201
  • ARCA Clinical Research Site #152
  • ARCA Clinical Research Site #161
  • ARCA Clinical Research Site #202
  • ARCA Clinical Research Site # 179
  • ARCA Clinical Research Site #397
  • ARCA Clinical Research Site #181
  • ARCA Clinical Research Site #349
  • ARCA Clinical Research Site #173
  • ARCA Clinical Research Site #392
  • ARCA Clinical Research Site #322
  • ARCA Clinical Research Site #151
  • ARCA Clinical Research Site #399
  • ARCA Clinical Research Site #115
  • ARCA Clinical Research Site # 189
  • ARCA Clinical Research Site #109
  • ARCA Clinical Research Site #133
  • ARCA Clinical Site #393
  • ARCA Clinical Research Site #198
  • ARCA Clinical Research Site #387
  • ARCA Clinical Research Site #379
  • ARCA Clinical Site #391
  • ARCA Clinical Research Site #386
  • ARCA Clinical Research Site #200
  • ARCA Research Site #131
  • ARCA Clinical Research Site #196
  • ARCA Clinical Research Site #612
  • ARCA Clinical Research Site #624
  • ARCA Clinical Research Site #611
  • ARCA Clinical Research Site #621
  • ARCA Clinical Research Site #601
  • ARCA Clinical Research Site #609
  • ARCA Clinical Research Site #623
  • ARCA Clinical Research Site #618
  • ARCA Clinical Research Site #613
  • ARCA Clinical Research Site #619
  • ARCA Clinical Research Site #616
  • ARCA Clinical Research Site #614
  • ARCA Clinical Research Site #607
  • ARCA Clinical Research Site #603
  • ARCA Clinical Research Site #625
  • ARCA Clinical Research Site #602
  • ARCA Clinical Research Site #626
  • ARCA Clinical Research Site #615
  • ARCA Clinical Research Site #726
  • ARCA Clinical Research Site #727
  • ARCA Clinical Research Site #728
  • ARCA Clinical Research Site #729
  • ARCA Clinical Research Site #733
  • ARCA Clinical Research Site #732
  • ARCA Clinical Research Site #730
  • ARCA Clinical Research Site #731
  • ARCA Clinical Research Site #734
  • ARCA Clinical Research Site #781
  • ARCA Clinical Research Site #779
  • ARCA Clinical Research Site #776
  • ARCA Clinical Research Site #780
  • ARCA Clinical Research Site #782
  • ARCA Clinical Research Site #786
  • ARCA Clinical Research Site #777
  • ARCA Clinical Research Site #783
  • ARCA Clinical Research Site #784
  • ARCA Clinical Research Site #752
  • ARCA Clinical Research Site #757
  • ARCA Clinical Research Site #753
  • ARCA Clinical Research Site #755
  • ARCA Clinical Research Site #751
  • ARCA Clinical Research Site #758
  • ARCA Clinical Research Site #754
  • ARCA Clinical Research Site #756
  • ARCA Clinical Research Site #807
  • ARCA Clinical Research Site #806
  • ARCA Clinical Research Site #801
  • ARCA Clinical Research Site #804
  • ARCA Clinical Research Site #805

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

bucindolol hydrochloride

metoprolol succinate

Arm Description

bucindolol hydrochloride (bucindolol) Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; < 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. 84% of bucindolol participants attained target dose and 72% of metoprolol participants attained target dose. The lowest starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the weight-based target dose or to the maximum tolerated dose. The starting dose assigned was based on the patient's beta-blocker treatment prior to randomization. Capsules for titration were available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.

metoprolol succinate (Toprol-XL) Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; < 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. 84% of bucindolol participants attained target dose and 72% of metoprolol participants attained target dose. The lowest starting dose of metoprolol was 25 mg QD with weekly dose titrations to the target dose or to the maximum tolerated dose. The starting dose assigned was based upon the patient's beta-blocker treatment prior to randomization. Capsules for titration were available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.

Outcomes

Primary Outcome Measures

Time to First Event of Symptomatic Atrial Fibrillation/Atrial Flutter (AF/AFL) or All Cause Mortality (ACM) During the 24-week Follow-up Period After Establishment of Stable Sinus Rhythm (SR) on Study Drug [End of Treatment Week 24].
Time-to-event is calculated as the date of the event minus the date of initiation of efficacy follow-up, with 1 added in order to include both the start date and end date of the interval. Cox's proportional hazards model will be used to calculate estimated hazard ratios and 95% confidence intervals. The calculations will be performed with the SAS PHREG procedure, with the stratification variables specified in the STRATA statement and the treatment group comparator and any covariates being examined specified in the MODEL statement. For the primary endpoint, the appropriateness of assuming proportional hazards will be explored by the graphing of log (-log(survival function)) over follow-up for each treatment group.

Secondary Outcome Measures

Time to First Event of Symptomatic or Asymptomatic AF/AFL or ACM During the 24-week Follow-up Period After Establishment of Stable SR on Study Drug [End of Treatment Week 24]
Number of days on study medication before participant experienced symptomatic or asymptomatic atrial fibrillation, atrial flutter, or all-cause mortality during the 24 week follow up period.
Number of Patients With Adequate Ventricular Rate Control During the 24-week Follow-up Period
Number of patients with adequate ventricular rate control following the start of medication during the 24-week Follow-up Period
Total Number of Hospitalization Days Per Patient (All-cause) During the Total Study Period (24 Weeks)
Total number of hospitalization days per patient (all-cause) following the start of study medication during the Total Study Period (24 weeks). Hospitalization was defined by a hospital admission (note that same day admit and discharge equates to 0 days duration), ER visits were not counted as events.

Full Information

First Posted
October 23, 2013
Last Updated
September 14, 2022
Sponsor
ARCA Biopharma, Inc.
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT01970501
Brief Title
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Acronym
GENETIC-AF
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 28, 2017 (Actual)
Study Completion Date
December 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ARCA Biopharma, Inc.
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Current or Recent History of Atrial Fibrillation
Keywords
atrial fibrillation, atrial flutter, heart failure, reduced left ventricle ejection fraction, electrical cardioversion, GENETIC-AF, Medtronic, bucindolol, pharmacogenetic, ARCA, Toprol, Toprol-XL, Metoprolol, Metoprolol succinate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
267 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bucindolol hydrochloride
Arm Type
Experimental
Arm Description
bucindolol hydrochloride (bucindolol) Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; < 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. 84% of bucindolol participants attained target dose and 72% of metoprolol participants attained target dose. The lowest starting dose of bucindolol was 6.25 mg BID with weekly dose titrations to the weight-based target dose or to the maximum tolerated dose. The starting dose assigned was based on the patient's beta-blocker treatment prior to randomization. Capsules for titration were available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
Arm Title
metoprolol succinate
Arm Type
Active Comparator
Arm Description
metoprolol succinate (Toprol-XL) Participants were randomized (1:1) to blinded treatment with bucindolol or metoprolol and titrated weekly to target doses of 50 mg twice daily (BID; < 75 kg) or 100 mg BID (≥ 75 kg) for bucindolol or 200 mg once daily (QD) for metoprolol. 84% of bucindolol participants attained target dose and 72% of metoprolol participants attained target dose. The lowest starting dose of metoprolol was 25 mg QD with weekly dose titrations to the target dose or to the maximum tolerated dose. The starting dose assigned was based upon the patient's beta-blocker treatment prior to randomization. Capsules for titration were available in the following dosage strengths to be taken twice daily (with or without food): 25mg, 50mg, 100mg, 200mg and/or matching placebo oral capsule to maintain blinded dosing.
Intervention Type
Drug
Intervention Name(s)
bucindolol hydrochloride
Other Intervention Name(s)
bucindolol
Intervention Type
Drug
Intervention Name(s)
metoprolol succinate
Other Intervention Name(s)
Toprol-XL, metoprolol
Intervention Type
Other
Intervention Name(s)
Placebo oral capsule
Other Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Time to First Event of Symptomatic Atrial Fibrillation/Atrial Flutter (AF/AFL) or All Cause Mortality (ACM) During the 24-week Follow-up Period After Establishment of Stable Sinus Rhythm (SR) on Study Drug [End of Treatment Week 24].
Description
Time-to-event is calculated as the date of the event minus the date of initiation of efficacy follow-up, with 1 added in order to include both the start date and end date of the interval. Cox's proportional hazards model will be used to calculate estimated hazard ratios and 95% confidence intervals. The calculations will be performed with the SAS PHREG procedure, with the stratification variables specified in the STRATA statement and the treatment group comparator and any covariates being examined specified in the MODEL statement. For the primary endpoint, the appropriateness of assuming proportional hazards will be explored by the graphing of log (-log(survival function)) over follow-up for each treatment group.
Time Frame
end of treatment week 24
Secondary Outcome Measure Information:
Title
Time to First Event of Symptomatic or Asymptomatic AF/AFL or ACM During the 24-week Follow-up Period After Establishment of Stable SR on Study Drug [End of Treatment Week 24]
Description
Number of days on study medication before participant experienced symptomatic or asymptomatic atrial fibrillation, atrial flutter, or all-cause mortality during the 24 week follow up period.
Time Frame
end of treatment week 24
Title
Number of Patients With Adequate Ventricular Rate Control During the 24-week Follow-up Period
Description
Number of patients with adequate ventricular rate control following the start of medication during the 24-week Follow-up Period
Time Frame
end of treatment week 24
Title
Total Number of Hospitalization Days Per Patient (All-cause) During the Total Study Period (24 Weeks)
Description
Total number of hospitalization days per patient (all-cause) following the start of study medication during the Total Study Period (24 weeks). Hospitalization was defined by a hospital admission (note that same day admit and discharge equates to 0 days duration), ER visits were not counted as events.
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Piccini, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Bristow, MD,PhD
Organizational Affiliation
ARCA Biopharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
ARCA Clinical Research Site #157
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
ARCA Clinical Research Site #383
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
ARCA Clinical Research Site #385
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
ARCA Clinical Research Site #381
City
East Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
ARCA Clinical Research Site #186
City
Loma Linda
State/Province
California
ZIP/Postal Code
92357
Country
United States
Facility Name
ARCA Clinical Research Site #320
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
ARCA Clinical Research Site #390
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
ARCA Clinical Research Site #153
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
ARCA Clinical Research Site #380
City
Denver
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
ARCA Clinical Research Site #195
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
ARCA Clinical Research Site #184
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
ARCA Clinical Research Site #351
City
Athens
State/Province
Georgia
ZIP/Postal Code
30606
Country
United States
Facility Name
ARCA Clinical Research Site #389
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
ARCA Clinical Research Site #342
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Facility Name
ARCA Clinical Research Site #303
City
Hammond
State/Province
Indiana
ZIP/Postal Code
46320
Country
United States
Facility Name
ARCA Clinical Research Site #388
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
ARCA Clinical Site #396
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
ARCA Clinical Research Site #398
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
ARCA Clinical Research Site #127
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
ARCA Clinical Research Site #156
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
ARCA Clinical Research Site #174
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
ARCA Clinical Research Site #108
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
ARCA Clinical Research Site #201
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
ARCA Clinical Research Site #152
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
ARCA Clinical Research Site #161
City
Elmer
State/Province
New Jersey
ZIP/Postal Code
08318
Country
United States
Facility Name
ARCA Clinical Research Site #202
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
ARCA Clinical Research Site # 179
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
ARCA Clinical Research Site #397
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
ARCA Clinical Research Site #181
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
ARCA Clinical Research Site #349
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
ARCA Clinical Research Site #173
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
ARCA Clinical Research Site #392
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
ARCA Clinical Research Site #322
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
ARCA Clinical Research Site #151
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
ARCA Clinical Research Site #399
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73135
Country
United States
Facility Name
ARCA Clinical Research Site #115
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
ARCA Clinical Research Site # 189
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
ARCA Clinical Research Site #109
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
ARCA Clinical Research Site #133
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
ARCA Clinical Site #393
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
ARCA Clinical Research Site #198
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
ARCA Clinical Research Site #387
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
ARCA Clinical Research Site #379
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
ARCA Clinical Site #391
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
ARCA Clinical Research Site #386
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
ARCA Clinical Research Site #200
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20109
Country
United States
Facility Name
ARCA Research Site #131
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
ARCA Clinical Research Site #196
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
ARCA Clinical Research Site #612
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
ARCA Clinical Research Site #624
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
ARCA Clinical Research Site #611
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Facility Name
ARCA Clinical Research Site #621
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 7R1
Country
Canada
Facility Name
ARCA Clinical Research Site #601
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
ARCA Clinical Research Site #609
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
ARCA Clinical Research Site #623
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 2P6
Country
Canada
Facility Name
ARCA Clinical Research Site #618
City
Oshawa
State/Province
Ontario
ZIP/Postal Code
L1H 1B9
Country
Canada
Facility Name
ARCA Clinical Research Site #613
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4W7
Country
Canada
Facility Name
ARCA Clinical Research Site #619
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
ARCA Clinical Research Site #616
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
Facility Name
ARCA Clinical Research Site #614
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
ARCA Clinical Research Site #607
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
ARCA Clinical Research Site #603
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A3
Country
Canada
Facility Name
ARCA Clinical Research Site #625
City
Saint-Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
ARCA Clinical Research Site #602
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
ARCA Clinical Research Site #626
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G8Z 3R9
Country
Canada
Facility Name
ARCA Clinical Research Site #615
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
ARCA Clinical Research Site #726
City
Budapest
ZIP/Postal Code
1096
Country
Hungary
Facility Name
ARCA Clinical Research Site #727
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
ARCA Clinical Research Site #728
City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
ARCA Clinical Research Site #729
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
ARCA Clinical Research Site #733
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
ARCA Clinical Research Site #732
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
ARCA Clinical Research Site #730
City
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
ARCA Clinical Research Site #731
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
ARCA Clinical Research Site #734
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
ARCA Clinical Research Site #781
City
Capelle aan den IJssel
ZIP/Postal Code
2906 ZC
Country
Netherlands
Facility Name
ARCA Clinical Research Site #779
City
Gorinchem
ZIP/Postal Code
4204 AA
Country
Netherlands
Facility Name
ARCA Clinical Research Site #776
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
ARCA Clinical Research Site #780
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
ARCA Clinical Research Site #782
City
Leiderdorp
ZIP/Postal Code
2334 CK
Country
Netherlands
Facility Name
ARCA Clinical Research Site #786
City
Roosendaal
ZIP/Postal Code
4708 AE
Country
Netherlands
Facility Name
ARCA Clinical Research Site #777
City
Sneek
ZIP/Postal Code
8601 ZK
Country
Netherlands
Facility Name
ARCA Clinical Research Site #783
City
Stadskanaal
ZIP/Postal Code
9501 HE
Country
Netherlands
Facility Name
ARCA Clinical Research Site #784
City
Tiel
ZIP/Postal Code
4002 WP
Country
Netherlands
Facility Name
ARCA Clinical Research Site #752
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
ARCA Clinical Research Site #757
City
Gdansk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
ARCA Clinical Research Site #753
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
ARCA Clinical Research Site #755
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
ARCA Clinical Research Site #751
City
Lodz
ZIP/Postal Code
92-213
Country
Poland
Facility Name
ARCA Clinical Research Site #758
City
Lublin
ZIP/Postal Code
20-954
Country
Poland
Facility Name
ARCA Clinical Research Site #754
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
Facility Name
ARCA Clinical Research Site #756
City
Wroclaw
ZIP/Postal Code
50-981
Country
Poland
Facility Name
ARCA Clinical Research Site #807
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
ARCA Clinical Research Site #806
City
Belgrade
ZIP/Postal Code
11080
Country
Serbia
Facility Name
ARCA Clinical Research Site #801
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
ARCA Clinical Research Site #804
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Facility Name
ARCA Clinical Research Site #805
City
Niš
ZIP/Postal Code
18000
Country
Serbia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16844790
Citation
Liggett SB, Mialet-Perez J, Thaneemit-Chen S, Weber SA, Greene SM, Hodne D, Nelson B, Morrison J, Domanski MJ, Wagoner LE, Abraham WT, Anderson JL, Carlquist JF, Krause-Steinrauf HJ, Lazzeroni LC, Port JD, Lavori PW, Bristow MR. A polymorphism within a conserved beta(1)-adrenergic receptor motif alters cardiac function and beta-blocker response in human heart failure. Proc Natl Acad Sci U S A. 2006 Jul 25;103(30):11288-93. doi: 10.1073/pnas.0509937103. Epub 2006 Jul 14.
Results Reference
background
PubMed Identifier
23071495
Citation
O'Connor CM, Fiuzat M, Carson PE, Anand IS, Plehn JF, Gottlieb SS, Silver MA, Lindenfeld J, Miller AB, White M, Walsh R, Nelson P, Medway A, Davis G, Robertson AD, Port JD, Carr J, Murphy GA, Lazzeroni LC, Abraham WT, Liggett SB, Bristow MR. Combinatorial pharmacogenetic interactions of bucindolol and beta1, alpha2C adrenergic receptor polymorphisms. PLoS One. 2012;7(10):e44324. doi: 10.1371/journal.pone.0044324. Epub 2012 Oct 10.
Results Reference
background
PubMed Identifier
24159564
Citation
Aleong RG, Sauer WH, Davis G, Murphy GA, Port JD, Anand IS, Fiuzat M, O'Connor CM, Abraham WT, Liggett SB, Bristow MR. Prevention of atrial fibrillation by bucindolol is dependent on the beta(1)389 Arg/Gly adrenergic receptor polymorphism. JACC Heart Fail. 2013 Aug;1(4):338-344. doi: 10.1016/j.jchf.2013.04.002.
Results Reference
background
PubMed Identifier
23223178
Citation
Kao DP, Davis G, Aleong R, O'Connor CM, Fiuzat M, Carson PE, Anand IS, Plehn JF, Gottlieb SS, Silver MA, Lindenfeld J, Miller AB, White M, Murphy GA, Sauer W, Bristow MR. Effect of bucindolol on heart failure outcomes and heart rate response in patients with reduced ejection fraction heart failure and atrial fibrillation. Eur J Heart Fail. 2013 Mar;15(3):324-33. doi: 10.1093/eurjhf/hfs181. Epub 2012 Dec 7.
Results Reference
background
PubMed Identifier
34270905
Citation
Piccini JP, Dufton C, Carroll IA, Healey JS, Abraham WT, Khaykin Y, Aleong R, Krueger SK, Sauer WH, Wilton SB, Rienstra M, van Veldhuisen DJ, Anand IS, White M, Camm AJ, Ziegler PD, Marshall D, Bristow MR, Connolly SJ; Genotype-Directed Comparative Effectiveness Trial of Bucindolol and Toprol-XL for Prevention of Atrial Fibrillation/Atrial Flutter in Patients with Heart Failure Trial Investigators*. Bucindolol Decreases Atrial Fibrillation Burden in Patients With Heart Failure and the ADRB1 Arg389Arg Genotype. Circ Arrhythm Electrophysiol. 2021 Aug;14(8):e009591. doi: 10.1161/CIRCEP.120.009591. Epub 2021 Jul 16.
Results Reference
derived
PubMed Identifier
29754666
Citation
Piccini JP, Connolly SJ, Abraham WT, Healey JS, Steinberg BA, Al-Khalidi HR, Dignacco P, van Veldhuisen DJ, Sauer WH, White M, Wilton SB, Anand IS, Dufton C, Marshall DA, Aleong RG, Davis GW, Clark RL, Emery LL, Bristow MR. A genotype-directed comparative effectiveness trial of Bucindolol and metoprolol succinate for prevention of symptomatic atrial fibrillation/atrial flutter in patients with heart failure: Rationale and design of the GENETIC-AF trial. Am Heart J. 2018 May;199:51-58. doi: 10.1016/j.ahj.2017.12.001. Epub 2017 Dec 6.
Results Reference
derived

Learn more about this trial

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

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