Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure (GENETIC-AF)
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ClinicalTrials.gov Identifier: NCT01970501 |
Recruitment Status
:
Completed
First Posted
: October 28, 2013
Last Update Posted
: January 9, 2018
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Sponsor:
ARCA Biopharma, Inc.
Collaborator:
Medtronic
Information provided by (Responsible Party):
ARCA Biopharma, Inc.
Tracking Information | |||||||
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First Submitted Date ICMJE | October 23, 2013 | ||||||
First Posted Date ICMJE | October 28, 2013 | ||||||
Last Update Posted Date | January 9, 2018 | ||||||
Study Start Date ICMJE | April 2014 | ||||||
Actual Primary Completion Date | December 28, 2017 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
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] [ Time Frame: end of treatment week 24 ] | ||||||
Original Primary Outcome Measures ICMJE |
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 conversion to stable sinus rhythm (SR) [ Time Frame: end of treatment week 24 ] | ||||||
Change History | Complete list of historical versions of study NCT01970501 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE |
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Original Other Outcome Measures ICMJE |
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Descriptive Information | |||||||
Brief Title ICMJE | Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure | ||||||
Official Title ICMJE | 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 | ||||||
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. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Current or Recent History of Atrial Fibrillation | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
267 | ||||||
Original Estimated Enrollment ICMJE |
620 | ||||||
Actual Study Completion Date | December 28, 2017 | ||||||
Actual Primary Completion Date | December 28, 2017 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 85 Years (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Canada, Hungary, Netherlands, Poland, Serbia, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01970501 | ||||||
Other Study ID Numbers ICMJE | BUC-CLIN-303 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement |
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Responsible Party | ARCA Biopharma, Inc. | ||||||
Study Sponsor ICMJE | ARCA Biopharma, Inc. | ||||||
Collaborators ICMJE | Medtronic | ||||||
Investigators ICMJE |
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PRS Account | ARCA Biopharma, Inc. | ||||||
Verification Date | January 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |