Status:
COMPLETED
SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Sanofi
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 as...
Detailed Description
BACKGROUND AND INTRODUCTION: Atrial fibrillation (AF) arises as a result of a complex interaction between triggers, perpetuators and substrate. As early as 1995, Morillo et al have demonstrated that ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01182376
Start Date
November 1 2010
End Date
December 1 2012
Last Update
February 19 2016
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