NCT01996943

The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study

Investigating the Effects of Ethanol on Atrial Fibrillation Susceptibility and Pathogenesis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 21 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it has been associated with ethanol use. Understanding how ethanol affects the electrical properties of the heart and induces AF has important public health implications. The objective of this research is to investigate the mechanistic relationship between ethanol and atrial fibrillation in humans by performing a placebo controlled study looking at the electrical properties of the heart in patients receiving intravenous ethanol or placebo. The investigators hypothesize that ethanol increases the susceptibility of human myocardium to atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute setting.

Detailed description

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.

Conditions

• Atrial Fibrillation
• Alcohol

Interventions

Type	Name	Description
DRUG	Ethanol	6% volume/volume ethanol in 0.45% saline solution.
DRUG	Placebo	The placebo with be 0.45% saline solution ("half normal saline").

Timeline

• Start date: 2012-09-01
• Primary completion: 2019-05-01
• Completion: 2020-05-01
• First posted: 2013-11-27
• Last updated: 2021-03-16
• Results posted: 2021-03-16

Locations

1 site across 1 country: United States