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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov Identifier:
NCT01182376
First received: August 11, 2010
Last updated: January 22, 2016
Last verified: January 2016
Results First Received: September 10, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Atrial Fibrillation
Interventions: Drug: dronedarone
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo

Half of the patients will be assigned placebo.

dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.

Multaq® (Dronedarone)

Half of the patients will be prescribed dronedarone.

dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.


Participant Flow:   Overall Study
    Placebo     Multaq® (Dronedarone)  
STARTED     15     18  
COMPLETED     4     13  
NOT COMPLETED     11     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo

Half of the patients will be assigned placebo.

dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.

Multaq® (Dronedarone)

Half of the patients will be prescribed dronedarone.

dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.

Total Total of all reporting groups

Baseline Measures
    Placebo     Multaq® (Dronedarone)     Total  
Number of Participants  
[units: participants]
  15     18     33  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     3     11     14  
>=65 years     12     7     19  
Age  
[units: years]
Mean (Standard Deviation)
  71  (8)     64  (11)     68  (10)  
Gender  
[units: participants]
     
Female     5     7     12  
Male     10     11     21  
Pre-treatment left atrial fibrosis percentage [1]
[units: percentage]
Mean (Standard Deviation)
  19.9  (.10)     15.5  (.05)     17.7  (.08)  
[1] Percentage of left atrial fibrosis is determined using an MRI image of the acutal fibrotic tissue located on the surface of the left atrium. Proprietary software is used to calculate fibrosis percentage based on the image. Fibrosis percentage can range from 0% to 40%. As a rule, the higher the percentage the worse the cardiovascular outcome of the patient.



  Outcome Measures

1.  Primary:   LA Fibrosis   [ Time Frame: baseline, 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Clinical Research Manager
Organization: University of Utah
phone: 8015873889
e-mail: christina.pacchia@hsc.utah.edu


Publications:


Responsible Party: Nassir F. Marrouche, MD, University of Utah
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board