SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: dronedarone; Placebo
Intervention description: Dronedarone will be prescribed by the patient's team according to established guidelines.; Placebo will be administered by the patient's team according to established guidelines.
Intervention MeSH terms: Dronedarone
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multaq; dronedarone; Atrial Fibrillation

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.
    

Eligibility 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