The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study
| Status: | Recruiting |
|---|---|
| Conditions: | Atrial Fibrillation |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 81 |
| Updated: | 1/31/2019 |
| Start Date: | September 2012 |
| End Date: | July 2019 |
| Contact: | Gregory M Marcus, MD, MAS |
| Email: | marcusg@medicine.ucsf.edu |
| Phone: | 415-476-5706 |
Investigating the Effects of Ethanol on Atrial Fibrillation Susceptibility and Pathogenesis
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.
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.
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.
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.
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 <50%,
inability to give informed consent, liver dysfunction (elevated aspartate
aminotransferase , alanine aminotransferase, total bilirubin, or alkaline phosphatase
>2x normal), clinical evidence of liver disease (enlarged liver, caput medusa, spider
angiomas, or other signs of liver disease on exam), or pregnancy.
We found this trial at
1
site
Click here to add this to my saved trials
