Trial Outcomes & Findings for Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes (NCT NCT01206452)
NCT ID: NCT01206452
Last Updated: 2017-05-17
Results Overview
Number of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
From 6 months up to 12 months post-procedure
Results posted on
2017-05-17
Participant Flow
Participant milestones
| Measure |
Ablation Plus Placebo
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Steroids Before Pulmonary Vein Isolation to Improve Outcomes
Baseline characteristics by cohort
| Measure |
Ablation Plus Placebo
n=30 Participants
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 Participants
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.23 years
STANDARD_DEVIATION 8.95 • n=5 Participants
|
63 years
STANDARD_DEVIATION 8.69 • n=7 Participants
|
63.12 years
STANDARD_DEVIATION 8.75 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.48 kg/m^2
STANDARD_DEVIATION 5.19 • n=5 Participants
|
30.53 kg/m^2
STANDARD_DEVIATION 5.93 • n=7 Participants
|
29.51 kg/m^2
STANDARD_DEVIATION 5.63 • n=5 Participants
|
|
AF Duration
|
7.92 years
STANDARD_DEVIATION 7.66 • n=5 Participants
|
4.98 years
STANDARD_DEVIATION 4.81 • n=7 Participants
|
6.45 years
STANDARD_DEVIATION 6.45 • n=5 Participants
|
PRIMARY outcome
Timeframe: From 6 months up to 12 months post-procedureNumber of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 6 and 12 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Outcome measures
| Measure |
Ablation Plus Placebo
n=30 Participants
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 Participants
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Number of Participants With Atrial Fibrillation Recurrence From 6 Months up to 12 Months
|
4 Participants with AF recurrence
|
6 Participants with AF recurrence
|
SECONDARY outcome
Timeframe: From 0 months up to 3 months post procedureNumber of AF recurrences between the two study groups as assessed by inpatient telemetry in the immediate post-procedure period until discharge and 1-month event monitor placed at 3 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Outcome measures
| Measure |
Ablation Plus Placebo
n=30 Participants
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 Participants
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Number of Participants With Atrial Fibrillation Recurrence From 0 Months up to 3 Months
|
6 Participants with AF recurrence
|
8 Participants with AF recurrence
|
SECONDARY outcome
Timeframe: From 3 months up to 6 months post-procedureNumber of AF recurrences between the two study groups as assessed by 1-month event monitor placed at 3 and 6 months post-ablation. Any episode of AF lasting greater than 30 seconds was counted as a recurrence.
Outcome measures
| Measure |
Ablation Plus Placebo
n=30 Participants
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 Participants
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Number of Participants With Atrial Fibrillation Recurrence From 3 Months up to 6 Months
|
5 Participants with AF recurrence
|
9 Participants with AF recurrence
|
SECONDARY outcome
Timeframe: Immediately Post-Ablation ProcedureMeasure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, immediately post-ablation in keeping with prior studies on the anti-inflammatory effects of steroids following cardiac surgery.
Outcome measures
| Measure |
Ablation Plus Placebo
n=30 Participants
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 Participants
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Inflammatory Cytokine Response to Ablation Procedure
IL-1 level
|
11 pg/ml
Standard Deviation 2.8
|
7.94 pg/ml
Standard Deviation 2.1
|
|
Inflammatory Cytokine Response to Ablation Procedure
IL-8 level
|
15.3 pg/ml
Standard Deviation 8.14
|
10.54 pg/ml
Standard Deviation 9.63
|
|
Inflammatory Cytokine Response to Ablation Procedure
TNF-α level
|
7.9 pg/ml
Standard Deviation 3.2
|
5.45 pg/ml
Standard Deviation 2.6
|
|
Inflammatory Cytokine Response to Ablation Procedure
IL-6 level
|
15.78 pg/ml
Standard Deviation 13.19
|
9.03 pg/ml
Standard Deviation 7.026
|
SECONDARY outcome
Timeframe: 24 Hours after Ablation ProcedureMeasure inflammatory marker levels, including IL-1, IL-6, IL-8, and TNF-α, 24 hours post-ablation to assess interval response to steroid administration.
Outcome measures
| Measure |
Ablation Plus Placebo
n=30 Participants
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 Participants
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Inflammatory Cytokine Response to Ablation Procedure
IL-1 level
|
11.7 pg/ml
Standard Deviation 15.4
|
8.5 pg/ml
Standard Deviation 12.1
|
|
Inflammatory Cytokine Response to Ablation Procedure
IL-8 level
|
59.6 pg/ml
Standard Deviation 54.9
|
63.9 pg/ml
Standard Deviation 52.8
|
|
Inflammatory Cytokine Response to Ablation Procedure
TNF-α level
|
9.7 pg/ml
Standard Deviation 15.8
|
7.5 pg/ml
Standard Deviation 16.1
|
|
Inflammatory Cytokine Response to Ablation Procedure
IL-6 level
|
40.9 pg/ml
Standard Deviation 39.9
|
40.2 pg/ml
Standard Deviation 49.7
|
Adverse Events
Ablation Plus Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ablation Plus Prednisone
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ablation Plus Placebo
n=30 participants at risk
Participants undergo ablation procedure and receive placebo at protocol determined times.
Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
Ablation Plus Prednisone
n=30 participants at risk
Participants undergo ablation procedure and receive predinisone at protocol determined times.
Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
Ablation Procedure: Atrial Fibrillation (AF) ablation
|
|---|---|---|
|
Blood and lymphatic system disorders
Groin hematoma
|
10.0%
3/30 • Number of events 3
|
6.7%
2/30 • Number of events 2
|
Additional Information
Donita Atkins, RN, CCRC
University of Kansas Medical Center
Phone: (913) 588-9714
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place