Phase 3 N=33 Randomized Double-blind Prevention

SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

Atrial Fibrillation

Bottom Line

View on ClinicalTrials.gov: NCT01182376 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2016

Primary outcome: Primary: LA Fibrosis — 24.6; 16.8 percentage of fibrosis

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: dronedarone (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Utah
Primary completion: Dec 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY LA Fibrosis	24.6; 16.8	—

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.

Eligibility 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 280 ms
Severe hepatic impairment
Pregnant women
Nursing mothers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01182376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.