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Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (GENETIC-AF)
This study is currently recruiting participants.
Verified July 2017 by ARCA Biopharma, Inc.
Sponsor:
ARCA Biopharma, Inc.
Collaborator:
Medtronic
Information provided by (Responsible Party):
ARCA Biopharma, Inc.
ClinicalTrials.gov Identifier:
NCT01970501
First received: October 23, 2013
Last updated: July 5, 2017
Last verified: July 2017
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Current or Recent History of Atrial Fibrillation | Drug: bucindolol hydrochloride Drug: metoprolol succinate | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial atrial fibrillation
Drug Information available for:
Succinic acid
Metoprolol
Metoprolol tartrate
Metoprolol fumarate
Metoprolol succinate
U.S. FDA Resources
Further study details as provided by ARCA Biopharma, Inc.:
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 [ Time Frame: end of treatment week 24 ]
Secondary Outcome Measures:
- Time to first event of AF/AFL (i.e., symptomatic or asymptomatic) or ACM during the 24-week Follow-up Period [ Time Frame: end of treatment week 24 ]
- Proportion of patients with ventricular tachycardia (VT), ventricular fibrillation (VF), or symptomatic supraventricular tachycardia (SVT) during the 24-week Follow-up Period [ Time Frame: end of treatment week 24 ]
- Total number of hospitalization days per patient (all-cause) during the Total Study Period [ Time Frame: 4 years ]
- Time to first event of AF/AFL (i.e., symptomatic or asymptomatic), heart failure (HF) hospitalization (as assessed by the Investigator), or ACM during the Total Study Period [ Time Frame: 4 years ]
- Proportion of patients with adequate ventricular rate control in the setting of AF/AFL [ Time Frame: 4 years ]
Other Outcome Measures:
- Incidence of ACM during the Total Study Period [ Time Frame: 4 years ]
- Incidence of ACM, cardiovascular-related hospitalization (as assessed by the Investigator), or withdrawal of study drug due to an adverse event (AE) during the Drug Titration Period [ Time Frame: end of treatment week 8 ]
- Incidence of heart block during the Total Study Period [ Time Frame: 4 years ]
- Incidence and severity of treatment-emergent Adverse Events/Serious Adverse Events over time during the Total Study Period [ Time Frame: 4 years ]
- Change from baseline (Visit 2) over time during the Total Study Period on: clinical laboratory tests, vital signs and weight, quantitative ECG parameters [ Time Frame: 4 years ]
- Proportion of patients attaining target study drug dose during the Drug Titration Period [ Time Frame: end of treatment week 8 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2014 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bucindolol hydrochloride
bucindolol 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. |
Drug: bucindolol hydrochloride
Other Name: bucindolol
|
|
Active Comparator: metoprolol succinate
metoprolol 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 to maintain blinded dosing. |
Drug: metoprolol succinate
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970501
Show 96 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01970501
Contacts
| Contact: Jennifer Meriwether | 720-940-2132 | jennifer.meriwether@arcabiopharma.com |
Show 96 Study Locations
Sponsors and Collaborators
ARCA Biopharma, Inc.
Medtronic
Investigators
| Principal Investigator: | Jonathan Piccini, MD | Duke University |
| Study Director: | Chris Dufton, PhD | ARCA Biopharma, Inc. |
More Information
Publications:
| Responsible Party: | ARCA Biopharma, Inc. |
| ClinicalTrials.gov Identifier: | NCT01970501 History of Changes |
| Other Study ID Numbers: |
BUC-CLIN-303 |
| Study First Received: | October 23, 2013 |
| Last Updated: | July 5, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by ARCA Biopharma, Inc.:
|
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 |
Additional relevant MeSH terms:
|
Heart Failure Atrial Fibrillation Atrial Flutter Heart Diseases Cardiovascular Diseases Arrhythmias, Cardiac Pathologic Processes Metoprolol Bucindolol Anti-Arrhythmia Agents Antihypertensive Agents Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |
ClinicalTrials.gov processed this record on July 28, 2017