Current or Recent History of Atrial Fibrillation | Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Current or Recent History of Atrial Fibrillation research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Current or Recent History of Atrial Fibrillation
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Other:Placebo oral capsule
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
bucindolol hydrochloridebucindolol hydrochloride (bucindolol) Capsules are available in the following dosage strengths to be taken twice daily (with or without food): 6.25mg, 12.5mg, 25mg, 50mg, and 100mg.
metoprolol succinatemetoprolol succinate (Toprol-XL) Capsules are 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.
Start Date: April 2014
Completed Date: December 28, 2017
Phase: Phase 2
Primary Outcome: Time to first event of symptomatic or asymptomatic 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]
Secondary Outcome: Time to first event of symptomatic AF/AFL or ACM during the 24-week Follow-up Period after establishment of stable SR on study drug [end of treatment week 24]
Study sponsors, principal investigator, and references
Principal Investigator: Jonathan Piccini, MD
Lead Sponsor: ARCA Biopharma, Inc.
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. Epub 2006 Jul 14.