The HOLIDAY (HOw ALcohol InDuces Atrial TachYarrhythmias) Study

NCT01996943 | Completed Results DMC

• 2 other identifiers: 12-085791R01AA022222-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Alcohol

Keywords

Atrial Fibrillation; Alcohol; Electrophysiologic properties of the atria; Randomized Clinical Study

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Atrial Fibrillation Induction

  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.

  This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion.

Secondary Outcomes (2)

• Change in Conduction Time

  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.

• Change in Atrial Effective Refractory Period (AERP)

  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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded.

Drug: Placebo

Ethanol

ACTIVE COMPARATOR

Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.

Drug: Ethanol

Interventions

Ethanol DRUG

6% volume/volume ethanol in 0.45% saline solution.

Also known as: Alcohol

Ethanol

Placebo DRUG

The placebo with be 0.45% saline solution ("half normal saline").

Also known as: Saline

Placebo

Eligibility Criteria

• Age: 21 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (1)

• Marcus GM, Dukes JW, Vittinghoff E, Nah G, Badhwar N, Moss JD, Lee RJ, Lee BK, Tseng ZH, Walters TE, Vedantham V, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Hue T, Olgin JE, Scheinman MM, Hsia H, Ramchandani VA, Gerstenfeld EP. A Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Alcohol to Assess Changes in Atrial Electrophysiology. JACC Clin Electrophysiol. 2021 May;7(5):662-670. doi: 10.1016/j.jacep.2020.11.026. Epub 2021 Jan 27.

  PMID: 33516710 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ethanol; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. Gregory Marcus
• Organization: University of California, San Francisco

Greg.Marcus@ucsf.edu

(415) 353-2554

Study Officials

• Gregory M Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Jonathan W Dukes, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: November 27, 2013
• Study Start: September 1, 2012
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: March 16, 2021
• Results First Posted: March 16, 2021

Record last verified: 2021-03

Locations

US (1)