Phase 2
N=267
Genetically Targeted Therapy for the Prevention of Symptomatic Atrial Fibrillation in Patients With Heart Failure
Current or Recent History of Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01970501 ↗Enrolled (actual)
267
Serious AEs
22.1%
Results posted
Sep 2022
Primary outcome: Primary: 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]. — 35.9; 33.2 days — p=0.905
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- bucindolol hydrochloride (Drug); metoprolol succinate (Drug); Placebo oral capsule (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ARCA Biopharma, Inc.
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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]. |
35.9; 33.2 | 0.905 |
| SECONDARY 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] |
37.86; 31.06 | 0.961 |
| SECONDARY Number of Patients With Adequate Ventricular Rate Control During the 24-week Follow-up Period |
84; 116 | — |
| SECONDARY Total Number of Hospitalization Days Per Patient (All-cause) During the Total Study Period (24 Weeks) |
2; 2 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01970501). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.