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

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ClinicalTrials.gov Identifier: NCT01182376
Recruitment Status : Completed
First Posted : August 16, 2010
Results First Posted : February 19, 2016
Last Update Posted : February 19, 2016
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah

Brief 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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Drug: dronedarone Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI
Study Start Date : November 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dronedarone

Arm Intervention/treatment
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®

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01182376

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

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Responsible Party: Nassir F. Marrouche, MD, Associate Professor of cardiology, University of Utah
ClinicalTrials.gov Identifier: NCT01182376    
Other Study ID Numbers: IRB_00040931
First Posted: August 16, 2010    Key Record Dates
Results First Posted: February 19, 2016
Last Update Posted: February 19, 2016
Last Verified: January 2016
Keywords provided by Nassir F. Marrouche, MD, University of Utah:
Atrial Fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents