Trial Outcomes & Findings for The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study (NCT NCT01996943)
NCT ID: NCT01996943
Last Updated: 2021-03-16
Results Overview
Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion.
Results posted on
2021-03-16
Participant Flow
Participant milestones
| Measure |
Placebo
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study
Baseline characteristics by cohort
| Measure |
Placebo
n=50 Participants
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
n=50 Participants
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Age, Continuous
|
61.14 years
STANDARD_DEVIATION 13.08 • n=99 Participants
|
58.78 years
STANDARD_DEVIATION 11.27 • n=107 Participants
|
60.51 years
STANDARD_DEVIATION 10.54 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=99 Participants
|
36 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=99 Participants
|
50 participants
n=107 Participants
|
100 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion.Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.
Outcome measures
| Measure |
Placebo
n=50 Participants
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
n=50 Participants
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
|---|---|---|
|
Number of Participants With Atrial Fibrillation Induction
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: This will be assessed during the experimental study from the Conduction Times that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion.The atrial conduction time will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in Conduction Time
Outcome measures
| Measure |
Placebo
n=50 Participants
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
n=50 Participants
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
|---|---|---|
|
Change in Conduction Time
hRA to low right atrium (lRA)
|
0.50 ms
Interval -2.67 to 5.33
|
0.50 ms
Interval -2.67 to 5.33
|
|
Change in Conduction Time
Paroximal coronary sinus (CSp) to high right atrium (hRA)
|
0.67 ms
Interval -1.33 to 2.67
|
0.33 ms
Interval -1.67 to 4.33
|
|
Change in Conduction Time
CSp to Left upper pulmonary vein (LUPV)
|
3.50 ms
Interval -2.0 to 12.83
|
2.88 ms
Interval -3.33 to 9.17
|
|
Change in Conduction Time
Distal coronary sinus (CSd) to CSp
|
0 ms
Interval -1.0 to 3.0
|
0.33 ms
Interval -2.0 to 2.33
|
|
Change in Conduction Time
hRA to His bundle (His)
|
-0.50 ms
Interval -2.5 to 10.67
|
-2.00 ms
Interval -5.0 to 1.33
|
|
Change in Conduction Time
LUPV to right upper pulmonary vein (RUPV)
|
3.67 ms
Interval -9.67 to 14.83
|
3.33 ms
Interval -10.0 to 11.83
|
|
Change in Conduction Time
RUPV to CSd
|
1 ms
Interval -6.0 to 7.67
|
2.33 ms
Interval -2.33 to 10.5
|
|
Change in Conduction Time
RUPV to His
|
0.33 ms
Interval -6.0 to 4.67
|
4.33 ms
Interval -4.0 to 11.0
|
SECONDARY outcome
Timeframe: This will be assessed during the experimental study from the AERPs that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion.The AERP will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in AERP
Outcome measures
| Measure |
Placebo
n=50 Participants
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
n=50 Participants
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
|---|---|---|
|
Change in Atrial Effective Refractory Period (AERP)
|
1.59 ms
Interval -4.96 to 8.14
|
-3.35 ms
Interval -9.89 to 3.18
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Ethanol
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=50 participants at risk
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
n=50 participants at risk
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tamponade
|
0.00%
0/50 • 1 year post-ablation
|
2.0%
1/50 • Number of events 1 • 1 year post-ablation
|
Other adverse events
| Measure |
Placebo
n=50 participants at risk
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
Placebo: The placebo with be 0.45% saline solution ("half normal saline").
|
Ethanol
n=50 participants at risk
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
|
|---|---|---|
|
General disorders
Hypotension
|
2.0%
1/50 • Number of events 1 • 1 year post-ablation
|
0.00%
0/50 • 1 year post-ablation
|
Additional Information
Dr. Gregory Marcus
University of California, San Francisco
Phone: (415) 353-2554
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place