SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to demonstrate how dronedarone (Multaq®) may aid in the slowing of progression of left atrial and ventricular fibrosis in patients with atrial fibrillation as assessed by late gadolinium enhanced magnetic resonance imaging.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Collaborator: Sanofi
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Dronedarone

Criteria

Inclusion Criteria:

• Patients age 18 and older

• Must carry a diagnosis of Paroxysmal Atrial Fibrillation for 1 months or longer prior to being enrolled.

• AAD: Multaq® (dronedarone) candidate

• Patients have given informed consent

Exclusion Criteria:

• Patients who are unavailable to continue follow-up at the University of Utah outpatient clinic.

• Patients weighing >200 lbs (MR image efficacy decreases due to density)

• Prior RF Ablation treatment for atrial fibrillation

• Severe renal failure manifested by a chronic GFR of < 30 mL/min, or acute renal failure regardless of the GFR, until the renal function has stabilized. (Gadolinium contraindication)

• Enrollment in any other investigational trial for anti-arrhythmic therapy

• Any health related Gadolinium/MRI contraindications: Pacemaker devices, etc.

• Pregnant women

• Individuals with cognitive impairments who are unable to give informed consent

• Multaq® (dronedarone) contraindications:

• NYHA Class IV heart failure or NYHA Class II - III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic

• Second- or third-degree atrioventricular (AV) block or sick sinus syndrome

• Bradycardia < 50 bpm

• Concomitant use of strong CYP 3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir

• Concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of Torsade de Pointes, such as phenothiazine anti-psychotics, tricyclic antidepressants, certain oral macrolide antibiotics, and Class I and III antiarrhythmics

• QTc Bazett interval ≥ 500 ms or PR interval > 280 ms

• Severe hepatic impairment

• Pregnant women

• Nursing mothers