The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study (HOLIDAY)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01996943|
Recruitment Status : Active, not recruiting
First Posted : November 27, 2013
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation Alcohol||Drug: Ethanol Drug: Placebo||Not Applicable|
The purpose of this study is to look for changes in the electrical properties of heart that may be caused by ethanol (commonly referred to as alcohol) and specifically how ethanol may trigger episodes of the most common abnormal heart rhythm, atrial fibrillation (AF). This study will demonstrate the mechanism of ethanol induced atrial fibrillation and clarify the health effects of one of the worlds' most popular drugs (ethanol). With this understanding, physicians may be able to better identify those patients most at risk for ethanol induced AF and target public health campaigns towards this vulnerable population.
Patients in this study will undergo an electrophysiologic study both prior to and after receiving either an ethanol or placebo infusion. This electrophysiology study will measure AF inducibility (the primary outcome), left and right atrial conduction times, and the atrial effective refractory period in multiple locations (AERP). The changes in the conduction times and AERPs (before and after study drug infusion) will be recorded as secondary outcomes.
About 100 people will participate in this study. 50 people will be randomized to receive intravenous ethanol, and 50 people will be randomized to receive an intravenous placebo. The placebo will be in the form of 0.45% saline solution ("half normal saline") and the alcohol will be in the form of 6% volume/volume ethanol in 0.45% saline solution.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Investigating the Effects of Ethanol on Atrial Fibrillation Susceptibility and Pathogenesis|
|Study Start Date :||September 2012|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2021|
Placebo Comparator: Placebo
The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.
The placebo with be 0.45% saline solution ("half normal saline").
Other Name: Saline
Active Comparator: Ethanol
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
6% volume/volume ethanol in 0.45% saline solution.
Other Name: Alcohol
- Atrial Fibrillation Induction [ Time Frame: 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.
- Change in Conduction Time [ Time Frame: 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
- Change in Atrial Effective Refractory Period (AERP) [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01996943
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Gregory M Marcus, MD, MAS||University of California, San Francisco|
|Principal Investigator:||Jonathan W Dukes, MD||University of California, San Francisco|