Trial · NCT01182376
SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI
NCT01182376, Phase 3, Completed, University of Utah; results first posted 2016-02-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI. Trials, record NCT01182376. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01182376
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- SOAR: Study Observing Antiarrhythmic Remodelling Using LGE-MRI
- NCT number
- NCT01182376
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 33 participants, actual
- Lead sponsor
- University of Utah
- Conditions
- Atrial Fibrillation
- Interventions
- dronedarone, Placebo
- First posted
- 2010-08-16
- Last updated
- 2016-02-19
- Results first posted
- 2016-02-19
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | LA Fibrosis | 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. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | LA Fibrosis | baseline, 1 year | The number of participants analyzed for both groups is less than the number enrolled due to patient attrition or poor MRI scans. | percentage of fibrosis | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| LA Fibrosis | Placebo | 24.6 | Standard Deviation .07 | percentage of fibrosis | |
| LA Fibrosis | Multaq® (Dronedarone) | 16.8 | Standard Deviation .05 | percentage of fibrosis |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | STARTED | Multaq® (Dronedarone) | 18 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | COMPLETED | Multaq® (Dronedarone) | 13 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Multaq® (Dronedarone) | 5 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 15 | |
| other | Nausea | Gastrointestinal disorders | Multaq® (Dronedarone) | 0 | 18 | |
| other | arrhythmias | Cardiac disorders | Placebo | 1 | 15 | |
| other | arrhythmias | Cardiac disorders | Multaq® (Dronedarone) | 0 | 18 | |
| other | non compliance | Social circumstances | Placebo | 5 | 15 | |
| other | non compliance | Social circumstances | Multaq® (Dronedarone) | 2 | 18 | |
| other | other surgeries | Surgical and medical procedures | Placebo | 2 | 15 | |
| other | other surgeries | Surgical and medical procedures | Multaq® (Dronedarone) | 3 | 18 | |
| other | drug interactions | General disorders | Placebo | 0 | 15 | |
| other | drug interactions | General disorders | Multaq® (Dronedarone) | 1 | 18 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Multaq® (Dronedarone) | ||
| Total, other adverse events | Placebo | 11 | 15 |
| Total, other adverse events | Multaq® (Dronedarone) | 6 | 18 |
| Total, serious adverse events | Placebo | 0 | 15 |
| Total, serious adverse events | Multaq® (Dronedarone) | 0 | 18 |
Source ClinicalTrials.gov
Papers15
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Multaq® (Dronedarone) vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01182376
GET https://conductscience.org/api/trials/v1/NCT01182376/registered