Trial Outcomes & Findings for SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI (NCT NCT01182376)

Last Updated: 2016-02-19

Results Overview

The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

33 participants

Primary outcome timeframe

baseline, 1 year

Results posted on

2016-02-19

Participant milestones
Measure	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.
Overall Study STARTED	15	18
Overall Study COMPLETED	4	13
Overall Study NOT COMPLETED	11	5

Withdrawal data not reported

SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI

Baseline characteristics by cohort
Measure	Placebo n=15 Participants Half of the patients will be assigned placebo. dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.	Multaq® (Dronedarone) n=18 Participants Half of the patients will be prescribed dronedarone. dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.	Total n=33 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	11 Participants n=7 Participants	14 Participants n=5 Participants
Age, Categorical >=65 years	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Age, Continuous	71 years STANDARD_DEVIATION 8 • n=5 Participants	64 years STANDARD_DEVIATION 11 • n=7 Participants	68 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	11 Participants n=7 Participants	21 Participants n=5 Participants
Pre-treatment left atrial fibrosis percentage	19.9 percentage STANDARD_DEVIATION .10 • n=5 Participants	15.5 percentage STANDARD_DEVIATION .05 • n=7 Participants	17.7 percentage STANDARD_DEVIATION .08 • n=5 Participants

Timeframe: baseline, 1 year

Population: The number of participants analyzed for both groups is less than the number enrolled due to patient attrition or poor MRI scans.

The change in left atrial fibrosis percentage, as measured on a scale, using MRI imaging, from baseline to the end of treatment.

Outcome measures
Measure	Placebo n=4 Participants Half of the patients will be assigned placebo. dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.	Multaq® (Dronedarone) n=12 Participants Half of the patients will be prescribed dronedarone. dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.
LA Fibrosis	24.6 percentage of fibrosis Standard Deviation .07	16.8 percentage of fibrosis Standard Deviation .05

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Placebo n=15 participants at risk Half of the patients will be assigned placebo. dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.	Multaq® (Dronedarone) n=18 participants at risk Half of the patients will be prescribed dronedarone. dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines.
Gastrointestinal disorders Nausea	20.0% 3/15	0.00% 0/18
Cardiac disorders arrhythmias	6.7% 1/15	0.00% 0/18
Social circumstances non compliance	33.3% 5/15	11.1% 2/18
Surgical and medical procedures other surgeries	13.3% 2/15	16.7% 3/18
General disorders drug interactions	0.00% 0/15	5.6% 1/18

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