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SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi-Aventis
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT01182376
First received: August 11, 2010
Last updated: September 28, 2012
Last verified: September 2012
History of Changes
  Purpose

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
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Dronedarone
U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • LA Fibrosis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The change from baseline to twelve months post initiation of the study treatments in left atrial fibrosis burden as measured by percentage of LGE-MRI.


Secondary Outcome Measures:
  • LA and LV Dimensional and Volumetric Measures [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Left atrial and ventricular dimensional and volumetric measurements by MR, as markers of disease progression/regression in the two arms of the study.


Enrollment: 60
Study Start Date: November 2010
Estimated Study Completion Date: December 2012
Estimated 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: dronedarone
Dronedarone will be prescribed by the patient's team according to established guidelines.
Other Names:
  • Multaq®
  • dronedarone
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 Names:
  • Multaq®
  • dronedarone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01182376

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

Publications:

Responsible Party: Nassir F. Marrouche, MD, Associate Professor of cardiology, University of Utah
ClinicalTrials.gov Identifier: NCT01182376     History of Changes
Other Study ID Numbers: IRB_00040931
Study First Received: August 11, 2010
Last Updated: September 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Multaq
dronedarone
Atrial Fibrillation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Arrhythmia Agents
Amiodarone
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents

ClinicalTrials.gov processed this record on October 17, 2012