Trial · NCT01198873
Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
NCT01198873, Phase 4, Terminated, Sanofi; results first posted 2013-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement. Trials, record NCT01198873. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01198873
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Dronedarone on Cardiac Geometry and Function in Patients With Atrial Fibrillation and Left Atrial Enlargement
- NCT number
- NCT01198873
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 76 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Atrial Fibrillation
- Interventions
- Dronedarone, Placebo (for Dronedarone)
- First posted
- 2010-09-10
- Last updated
- 2013-02-12
- Results first posted
- 2013-02-12
- Limitations and caveats
Due to the early termination of the study, results should be cautiously interpreted. Indeed the number of participants was lower than planned (76 instead of 334) and the treatment period was shorter than planned (6 months instead of 12 months).
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Left Atrial Volume Index (LAVi) | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | Left Atrial Volume index (LAVi) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis. |
| Secondary | Changes From Baseline in Left Atrial Function | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | left atrial (LA) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis. |
| Secondary | Changes From Baseline in Left Atrial Dimension | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | Maximal left atrial diameter in the anteroposterior dimension was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis. |
| Secondary | Changes From Baseline in Left Ventricular Ejection Fraction (LVEF) | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | Left Ventricular Ejection Fraction (LVEF) was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last drug intake and data were included in the analysis. |
| Secondary | Changes From Baseline in Left Ventricular Function | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | left ventricular (LV) function was assessed at baseline and after 12 months treatment using 2-D echocardiography and interpreted blindly via a central Echocardiography Core Lab. Participants who discontinued after completing at least 3 months of treatment were assessed after last study drug intake and data were included in the analysis. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Left Atrial Volume Index (LAVi) | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | The analysis included all randomized and treated participants with at least one post-baseline echocardiographic assessment. Participants were included in the treatment group to which they were randomized (Modified Intent-to-treat analysis).~The quality of the post-baseline echocardiography was inadequate for determining LAVi in one participant. | mililiters/m2 | MEAN |
| SECONDARY | Changes From Baseline in Left Atrial Function | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | Modified intent-to-treat population as previously defined | mililiters | MEAN |
| SECONDARY | Changes From Baseline in Left Atrial Dimension | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | Modified intent-to-treat population as previously defined | centimeters | MEAN |
| SECONDARY | Changes From Baseline in Left Ventricular Ejection Fraction (LVEF) | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | Modified intent-to-treat population as previously defined | percentage of blood pumped out | MEAN |
| SECONDARY | Changes From Baseline in Left Ventricular Function | baseline (before randomization) and post-baseline (after 3-12 months of treatment) | centimeters/second | MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Left Atrial Volume Index (LAVi) | Placebo | Baseline (n =33, 26) | 37.555 | Standard Deviation 5.899 | mililiters/m2 |
| Change From Baseline in Left Atrial Volume Index (LAVi) | Dronedarone | Baseline (n =33, 26) | 37.715 | Standard Deviation 6.597 | mililiters/m2 |
| Change From Baseline in Left Atrial Volume Index (LAVi) | Placebo | Post-baseline (n =32, 26) | 29.191 | Standard Deviation 5.994 | mililiters/m2 |
| Change From Baseline in Left Atrial Volume Index (LAVi) | Dronedarone | Post-baseline (n =32, 26) | 30.823 | Standard Deviation 5.364 | mililiters/m2 |
| Change From Baseline in Left Atrial Volume Index (LAVi) | Placebo | Change from baseline (n =32, 26) | -8.438 | Standard Deviation 4.743 | mililiters/m2 |
| Change From Baseline in Left Atrial Volume Index (LAVi) | Dronedarone | Change from baseline (n =32, 26) | -6.892 | Standard Deviation 5.759 | mililiters/m2 |
| Changes From Baseline in Left Atrial Function | Placebo | LA passive emptying volume (n = 19, 19) | -10.783 | Standard Deviation 7.798 | mililiters |
| Changes From Baseline in Left Atrial Function | Dronedarone | LA passive emptying volume (n = 19, 19) | -4.566 | Standard Deviation 9.094 | mililiters |
| Changes From Baseline in Left Atrial Function | Placebo | LA conduit volume (n =29, 25) | -1.366 | Standard Deviation 5.652 | mililiters |
| Changes From Baseline in Left Atrial Function | Dronedarone | LA conduit volume (n =29, 25) | -0.764 | Standard Deviation 5.759 | mililiters |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 41 | |
| Overall Study | STARTED | Dronedarone | 35 | |
| Overall Study | Treated | Placebo | 41 | |
| Overall Study | Treated | Dronedarone | 35 | |
| Overall Study | Evaluable for Efficacy | Placebo | 33 | |
| Overall Study | Evaluable for Efficacy | Dronedarone | 26 | |
| Overall Study | COMPLETED | Placebo | 4 | |
| Overall Study | COMPLETED | Dronedarone | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Dronedarone | 32 |
Source ClinicalTrials.gov
Adverse events44
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 | Pneumonia | Infections and infestations | Placebo | 0 | 41 | |
| other | Pneumonia | Infections and infestations | Dronedarone | 2 | 35 | |
| other | Sinusitis | Infections and infestations | Placebo | 0 | 41 | |
| other | Sinusitis | Infections and infestations | Dronedarone | 2 | 35 | |
| other | Insomnia | Psychiatric disorders | Placebo | 0 | 41 | |
| other | Insomnia | Psychiatric disorders | Dronedarone | 3 | 35 | |
| other | Depression | Psychiatric disorders | Placebo | 0 | 41 | |
| other | Depression | Psychiatric disorders | Dronedarone | 2 | 35 | |
| other | Dizziness | Nervous system disorders | Placebo | 0 | 41 | |
| other | Dizziness | Nervous system disorders | Dronedarone | 3 | 35 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Dronedarone | ||
| Total, other adverse events | Placebo | 5 | 41 |
| Total, other adverse events | Dronedarone | 14 | 35 |
| Total, serious adverse events | Placebo | 1 | 41 |
| Total, serious adverse events | Dronedarone | 5 | 35 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| 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/NCT01198873
GET https://conductscience.org/api/trials/v1/NCT01198873/results?page=2