Trial Outcomes & Findings for Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation (NCT NCT04792190)
NCT ID: NCT04792190
Last Updated: 2024-12-04
Results Overview
For the primary endpoint of AF burden, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a patient was monitored), the student's t-test will be used to statistically compare the placebo group vs. the active treatment group. This approach is subject to an examination of the distribution of the percent time in AF. AF data will be collected using a cardiac implantable electronic device (CIED). AF burden assessed at 6-12 months following catheter ablation of AF, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a subject was monitored).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
25 participants
Primary outcome timeframe
12 months
Results posted on
2024-12-04
Participant Flow
Participant milestones
| Measure |
Intervention Management Arm (Dapagliflozin)
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Intervention Management Arm (Dapagliflozin)
n=12 Participants
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=13 Participants
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
STANDARD_DEVIATION 12 • n=5 Participants
|
67 years
STANDARD_DEVIATION 10 • n=7 Participants
|
64 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsFor the primary endpoint of AF burden, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a patient was monitored), the student's t-test will be used to statistically compare the placebo group vs. the active treatment group. This approach is subject to an examination of the distribution of the percent time in AF. AF data will be collected using a cardiac implantable electronic device (CIED). AF burden assessed at 6-12 months following catheter ablation of AF, defined as percentage of time spent in AF (i.e. amount of time spent in AF divided by the total amount of time a subject was monitored).
Outcome measures
| Measure |
Intervention Management Arm (Dapagliflozin)
n=12 Participants
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=13 Participants
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Mean Percentage of Time Spent in Atrial Fibrillation
|
2.74 percentage of time
Standard Deviation 6.31
|
5.85 percentage of time
Standard Deviation 12.85
|
SECONDARY outcome
Timeframe: 6-12 monthsRate of health care utilization (recurrent hospitalizations, unplanned office visits, need for emergency room visits)
Outcome measures
| Measure |
Intervention Management Arm (Dapagliflozin)
n=12 Participants
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=13 Participants
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Rate of Health Care Utilization
|
132 events
|
104 events
|
SECONDARY outcome
Timeframe: 6-12 monthsOutcome measures
| Measure |
Intervention Management Arm (Dapagliflozin)
n=12 Participants
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=13 Participants
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Percentage of Participants Hospitalized for Heart Failure Post Catheter Ablation of AF
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Final visit, approximately 12 monthsThe AFEQT questionnaire is an AF-specific health-related quality of life questionnaire designed to be used in clinical research. The responses on the AFEQT are scored on a Likert scale, 1 = "Not at all…" to 7 = "Extremely". Scores range from 0 to 100. A score of 0 corresponds to complete disability and a score of 100 corresponds to no disability.
Outcome measures
| Measure |
Intervention Management Arm (Dapagliflozin)
n=3 Participants
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=3 Participants
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Mean Quality of Life Score Using the QualiTy-of-life (AFEQT) Questionnaire
|
20.7 score on a scale
Standard Deviation 8.8
|
15.4 score on a scale
Standard Deviation 26.8
|
Adverse Events
Intervention Management Arm (Dapagliflozin)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Control Arm (Placebo)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention Management Arm (Dapagliflozin)
n=12 participants at risk
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=13 participants at risk
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Cardiac disorders
Ventricular Fibrillation
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Cardiac disorders
Myocardial Infarction
|
8.3%
1/12 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
Other adverse events
| Measure |
Intervention Management Arm (Dapagliflozin)
n=12 participants at risk
A block randomization method will be use to randomize subjects to treatment with dapagliflozin 10 mg once daily. Subjects will take 1 blinded tablet of study drug (dapagliflozin) dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
dapagliflozin: Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
|
Control Arm (Placebo)
n=13 participants at risk
Subjects will take 1 blinded tablet of placebo drug dosed once daily, per the randomization scheme, for 12 months. Each subject will be dispensed 35 blinded doses per month, during each month of participation in the trial. Quarterly pill counts will be performed to track compliance.
Placebo: Subjects will take 1 blinded capsule of placebo drug dosed once daily
|
|---|---|---|
|
Gastrointestinal disorders
nausea
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Endocrine disorders
hypoglycemia
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Eye disorders
eye pain
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Nervous system disorders
forgetfullness
|
0.00%
0/12 • 1 year
|
7.7%
1/13 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Malaise
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Renal and urinary disorders
Urinary Tract Infection
|
16.7%
2/12 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Atrial fibrillation
|
8.3%
1/12 • 1 year
|
0.00%
0/13 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place