N/A
N=100
The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study
Atrial Fibrillation · Alcohol
Bottom Line
View on ClinicalTrials.gov: NCT01996943 ↗Enrolled (actual)
100
Serious AEs
1.0%
Results posted
Mar 2021
Primary outcome: Primary: Number of Participants With Atrial Fibrillation Induction — 22; 24 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ethanol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Atrial Fibrillation Induction |
22; 24 | — |
| SECONDARY Change in Conduction Time |
0.67; 0.33; 3.50; 2.88; 0; 0.33 | — |
| SECONDARY Change in Atrial Effective Refractory Period (AERP) |
1.59; -3.35 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients aged 21-80 with paroxysmal atrial fibrillation (AF), supraventricular tachycardia, or undifferentiated palpitations who are to undergo either an elective ablation procedure (for AF, atrial flutter, atria tachycardia, atrial ventricular nodal reentrant tachycardia (AVNRT), or atrial ventricular reentrant tachycardia (AVRT)) or a diagnostic electrophysiology study in order to diagnose and treat their clinical arrhythmia at the University of California, San Francisco (UCSF) will be eligible for enrollment.
Exclusion criteria
- Patients will be excluded if they are not in normal sinus rhythm (i.e. in AF, atrial tachycardia, atrial flutter, or incessant AVNRT/AVRT) at the time of onset of the procedure, any history of substance abuse or alcoholism as determined by history, AUDIT questionnaire, or chart review, left ventricular ejection fraction 2x normal), clinical evidence of liver disease (enlarged liver, caput medusa, spider angiomas, or other signs of liver disease on exam), or pregnancy.
Data sourced from ClinicalTrials.gov (NCT01996943). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.