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
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|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Drug: dronedarone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||33 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
Placebo Comparator: Placebo
Half of the patients will be assigned 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.
Dronedarone will be prescribed by the patient's team according to established guidelines.
Other Name: Multaq®
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
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
|Principal Investigator:||Nassir F Marrouche, MD||University of Utah|
|Responsible Party:||Nassir F. Marrouche, MD, Associate Professor of cardiology, University of Utah|
|Other Study ID Numbers:||
|First Posted:||August 16, 2010 Key Record Dates|
|Results First Posted:||February 19, 2016|
|Last Update Posted:||February 19, 2016|
|Last Verified:||January 2016|