A Study of IV HBI-3000 for the Conversion Recent Onset Atrial Fibrillation (AF)
Atrial Fibrillation
About this trial
This is an interventional treatment trial for Atrial Fibrillation focused on measuring cardioversion
Eligibility Criteria
Inclusion Criteria:
- 18 to 80 years of age
- Sustained AF of > 2 hours and < 72 hours duration
- Eligible for cardioversion (electrical and pharmacologic)
- On adequate anticoagulant therapy or eligible for anticoagulation during treatment and for at least 30 days duration after treatment if indicated by ACC/AHA/HRS or country specific national or international guidelines for thromboembolic risk reduction related to AF
Exclusion Criteria:
- Atrial fibrillation < 2 hours or > 72 hours duration or with duration not reliably established at the time of dosing
- Hemodynamic instability that may require emergency electrical cardioversion
- Atrial flutter
- Moderate to severe HF
- Clinical or ECG signs of acute cardiac ischemia or digitalis toxicity
- Known or suspected hyperthyroidism
- Cardiac surgery, stroke, TIA, acute MI/ PCI, unstable angina, or persistent angina at rest within the previous 3 months
- Presence of LA thrombus by TEE or TTE
- Presence of concurrent myocarditis or endocarditis
- ECG abnormalities: Current QTcF > 480 msec; QRS interval > 120 msec and/or a complete bundle branch block (BBB)l Delta wave or other pre-excitation pattern consistent with WPW syndrome; Acute coronary ischemia patterns
- Use of medication that prolongs the QTc interval or history of: Long QT syndrome, congenital or acquired; Torsades de Pointes (TdP); Brugada Syndrome; Ventricular arrhythmia (not including infrequent isolated PVC)
- Concurrent treatment with Class I or III antiarrhythmic drugs, metformin or strong CYP2D6 inhibitors (unless the medication is discontinued > 5 half-lives before enrollment)
- Treatment with oral amiodarone in the previous 3 months or IV amiodarone administered within 24 hours prior to planned Study Drug administration
- Use of vernakalant, or any experimental drug within 30 days or five half-lives (whichever is longer) of Study Drug administration, or use of an invasive investigational medical device within 2 months prior to Study Drug administration, or current enrollment in another study with investigational agent or procedure
- Clinically significant laboratory abnormalities
Sites / Locations
- Grandview Medical Group Research
- HonorHealth Research Institute and InnovationRecruiting
- NCH Research InstituteRecruiting
- Research Physicians Network Alliance/Florida Cardiology
- Prairie Education & Research
- St. Vincent Heart CenterRecruiting
- Lutheran Hospital
- UofL Health - UofL Physicians, Cardiology AssociatesRecruiting
- North Mississippi Medical CenterRecruiting
- AMG Heart and Vascular CenterRecruiting
- Ascension St. John Clinical Research InstituteRecruiting
- CHRISTUS Trinity Mother Frances Hospital - TylerRecruiting
- Gold Coast University HospitalRecruiting
- University Clinical Center of the Republic of SrpskaRecruiting
- University Clinical Center TuzlaRecruiting
- Montreal Heart InstituteRecruiting
- Centre hospitalier de L'Universite de Montral (CHUM)Recruiting
- Centre integre de sante et de services sociaux de Lanaudiere - Hopital Pierre-Le GardeurRecruiting
- Seoul National University Bundang HospitalRecruiting
- Chonnam National University HospitalRecruiting
- Auckland City Hospital
- Waikato Hospital
- Wellington Regional HospitalRecruiting
- University Clinical Center of SerbiaRecruiting
- University Hospital Medical Center Bezanijska kosaRecruiting
- Clinical Hospital Center ZvezdaraRecruiting
- Health Center UziceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Drug: HBI-3000, Stage A Dose Level 1
Drug: HBI-3000, Stage A Dose Level 2
Drug: HBI-3000, Stage A Dose Level 3
Drug: HBI-3000, Stage B Dose Level 1
Drug: HBI-3000, Stage B Dose Level 2
Stage A Open Label HBI-3000 Dose Level 1: 200 mg
Stage A Open Label HBI-3000 Dose Level 2: 350 mg planned
Stage A Open Label HBI-3000 Dose Level 2: 500 mg planned
Stage B Double-blind placebo controlled, Cohort 1 HBI-3000 Dose Level 1: Selected based on Stage A results
Stage B Double-blind placebo controlled, Cohort 2 HBI-3000 Dose Level 2: Selected based on Stage A, and Stage B Cohort 1 results