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SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI (SOAR)

This study has been completed.
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah Identifier:
First received: August 11, 2010
Last updated: January 22, 2016
Last verified: January 2016
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.

Condition Intervention Phase
Atrial Fibrillation Drug: dronedarone Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

Resource links provided by NLM:

Further study details as provided by Nassir F. Marrouche, MD, University of Utah:

Primary Outcome Measures:
  • LA Fibrosis [ Time Frame: baseline, 1 year ]
    The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.

Enrollment: 33
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Half of the patients will be assigned placebo.
Drug: Placebo
Placebo will be administered by the patient's team according to established guidelines.
Experimental: Multaq® (dronedarone)
Half of the patients will be prescribed dronedarone.
Drug: dronedarone
Dronedarone will be prescribed by the patient's team according to established guidelines.
Other Name: Multaq®

  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01182376

Sponsors and Collaborators
University of Utah
Principal Investigator: Nassir F Marrouche, MD University of Utah
  More Information


Responsible Party: Nassir F. Marrouche, MD, Associate Professor of cardiology, University of Utah Identifier: NCT01182376     History of Changes
Other Study ID Numbers: IRB_00040931
Study First Received: August 11, 2010
Results First Received: September 10, 2015
Last Updated: January 22, 2016

Keywords provided by Nassir F. Marrouche, MD, University of Utah:
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Vasodilator Agents
Potassium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Sodium Channel Blockers
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 CYP3A Inhibitors processed this record on September 21, 2017