Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

NCT06754176 | Recruiting

• 2 other identifiers: 24-41856R01AA022222
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is: Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment? Participants will:

• Be given daily random assignments to avoid or not to avoid alcohol
• Wear an adhesive electrocardiographic (ECG) heart monitor
• Wear a wrist-worn fitness tracker
• Wear an anklet transdermal alcohol monitor
• Wear an adhesive glucose monitor
• Complete morning and evening surveys daily Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation (Paroxysmal)

Keywords

Alcohol; Drinking; Mediterranean Drinking Pattern; Atrial Fibrillation; AFib; AF; Heart Rhythm

Outcome Measures

Primary Outcomes (1)

• Presence or Absence of Discrete Atrial Fibrillation Episodes

  Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be the presence (versus absence) of at least one AFib episode on randomly assigned drinking versus non-drinking days.

  2 weeks

Secondary Outcomes (4)

• As-Treated Relationships versus the Presence of AFib

  2 weeks

• Daily Glucose Levels

  2 weeks

• Step Counts

  2 weeks

• Sleep Duration

  2 weeks

Study Arms (2)

Alcohol Non-Avoidance Case-Crossover Arm

EXPERIMENTAL

On a given day of the 14-day study period, participants may be randomly assigned to not avoid consuming alcohol. All participants will be instructed that any alcohol consumed should not be more than 2 drinks in a 24 hour period for men and not more than 1 drink in a 24 hour period for women. The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row. Participants will press a button on their continuously recording ECG monitor to time-stamp every alcohol drink consumed.

Behavioral: Alcohol Consumption Randomized Instructions

Alcohol Avoidance Case-Crossover Arm

EXPERIMENTAL

On a given day of the 14-day study period, participants may be randomly assigned to avoid consuming alcohol. The frequency of randomization will be tailored to the baseline usual frequency of alcohol consumption: For example, those who drink an average of 4 days a week/don't drink 3 days a week will have their randomization programmed to assure an average of 7 non-drinking days over the two-week period. Participants will not receive the same randomization assignment more than two consecutive days in a row.

Behavioral: Alcohol Consumption Randomized Instructions

Interventions

Alcohol Consumption Randomized Instructions BEHAVIORAL

Alcohol Avoidance: In this intervention assignment, participants will be instructed to avoid drinking alcohol for this day. Alcohol Non-Avoidance: In this intervention assignment, participants will be allowed to drink alcohol for this day.

Alcohol Avoidance Case-Crossover Arm; Alcohol Non-Avoidance Case-Crossover Arm

Eligibility Criteria

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

You may qualify if:

• Comfortable reading and writing in English
• Have a smartphone and willing and able to use the Eureka mobile application
• Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period
• At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month
• Drank alcohol at least 1 day/week on average in the past month
• Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period
• Willing and able to provide written informed consent

You may not qualify if:

• Only post-operative AFib
• Greater than 40% ventricular pacing
• History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
• Intolerance to alcohol
• History of liver disease
• Currently incarcerated
• Currently pregnant or trying to get pregnant

Sponsors & Collaborators

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

Study Sites (2)

UCSF Medical Center at Parnassus

San Francisco, California, 94143, United States

RECRUITING

UCSF Medical Center at Mission Bay

San Francisco, California, 94158, United States

RECRUITING

Related Publications (22)

• Benjamin EJ, Al-Khatib SM, Desvigne-Nickens P, Alonso A, Djousse L, Forman DE, Gillis AM, Hendriks JML, Hills MT, Kirchhof P, Link MS, Marcus GM, Mehra R, Murray KT, Parkash R, Pina IL, Redline S, Rienstra M, Sanders P, Somers VK, Van Wagoner DR, Wang PJ, Cooper LS, Go AS. Research Priorities in the Secondary Prevention of Atrial Fibrillation: A National Heart, Lung, and Blood Institute Virtual Workshop Report. J Am Heart Assoc. 2021 Aug 17;10(16):e021566. doi: 10.1161/JAHA.121.021566. Epub 2021 Aug 5.

  PMID: 34351783 BACKGROUND

• Chung MK, Eckhardt LL, Chen LY, Ahmed HM, Gopinathannair R, Joglar JA, Noseworthy PA, Pack QR, Sanders P, Trulock KM; American Heart Association Electrocardiography and Arrhythmias Committee and Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; and Council on Lifestyle and Cardiometabolic Health. Lifestyle and Risk Factor Modification for Reduction of Atrial Fibrillation: A Scientific Statement From the American Heart Association. Circulation. 2020 Apr 21;141(16):e750-e772. doi: 10.1161/CIR.0000000000000748. Epub 2020 Mar 9.

  PMID: 32148086 BACKGROUND

• Voskoboinik A, Kalman JM, De Silva A, Nicholls T, Costello B, Nanayakkara S, Prabhu S, Stub D, Azzopardi S, Vizi D, Wong G, Nalliah C, Sugumar H, Wong M, Kotschet E, Kaye D, Taylor AJ, Kistler PM. Alcohol Abstinence in Drinkers with Atrial Fibrillation. N Engl J Med. 2020 Jan 2;382(1):20-28. doi: 10.1056/NEJMoa1817591.

  PMID: 31893513 BACKGROUND

• Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21. doi: 10.1136/heart.86.5.516.

  PMID: 11602543 BACKGROUND

• Mukamal KJ, Tolstrup JS, Friberg J, Jensen G, Gronbaek M. Alcohol consumption and risk of atrial fibrillation in men and women: the Copenhagen City Heart Study. Circulation. 2005 Sep 20;112(12):1736-42. doi: 10.1161/CIRCULATIONAHA.105.547844. Epub 2005 Sep 12.

  PMID: 16157768 BACKGROUND

• Mukamal KJ, Psaty BM, Rautaharju PM, Furberg CD, Kuller LH, Mittleman MA, Gottdiener JS, Siscovick DS. Alcohol consumption and risk and prognosis of atrial fibrillation among older adults: the Cardiovascular Health Study. Am Heart J. 2007 Feb;153(2):260-6. doi: 10.1016/j.ahj.2006.10.039.

  PMID: 17239687 BACKGROUND

• Frost L, Vestergaard P. Alcohol and risk of atrial fibrillation or flutter: a cohort study. Arch Intern Med. 2004 Oct 11;164(18):1993-8. doi: 10.1001/archinte.164.18.1993.

  PMID: 15477433 BACKGROUND

• Djousse L, Levy D, Benjamin EJ, Blease SJ, Russ A, Larson MG, Massaro JM, D'Agostino RB, Wolf PA, Ellison RC. Long-term alcohol consumption and the risk of atrial fibrillation in the Framingham Study. Am J Cardiol. 2004 Mar 15;93(6):710-3. doi: 10.1016/j.amjcard.2003.12.004.

  PMID: 15019874 BACKGROUND

• Engel TR, Luck JC. Effect of whiskey on atrial vulnerability and "holiday heart". J Am Coll Cardiol. 1983 Mar;1(3):816-8. doi: 10.1016/s0735-1097(83)80195-8.

  PMID: 6826972 BACKGROUND

• Lowenstein SR, Gabow PA, Cramer J, Oliva PB, Ratner K. The role of alcohol in new-onset atrial fibrillation. Arch Intern Med. 1983 Oct;143(10):1882-5.

  PMID: 6625772 BACKGROUND

• Ettinger PO, Wu CF, De La Cruz C Jr, Weisse AB, Ahmed SS, Regan TJ. Arrhythmias and the "Holiday Heart": alcohol-associated cardiac rhythm disorders. Am Heart J. 1978 May;95(5):555-62. doi: 10.1016/0002-8703(78)90296-x. No abstract available.

  PMID: 636996 BACKGROUND

• Koskinen P, Kupari M, Leinonen H, Luomanmaki K. Alcohol and new onset atrial fibrillation: a case-control study of a current series. Br Heart J. 1987 May;57(5):468-73. doi: 10.1136/hrt.57.5.468.

  PMID: 3593617 BACKGROUND

• 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 BACKGROUND

• Aung S, Nah G, Vittinghoff E, Groh CA, Fang CD, Marcus GM. Population-Level Analyses of Alcohol Consumption as a Predictor of Acute Atrial Fibrillation Episodes. Nat Cardiovasc Res. 2022 Jan;1(1):23-27. doi: 10.1038/s44161-021-00003-7. Epub 2022 Jan 12. No abstract available.

  PMID: 38037649 BACKGROUND

• McManus DD, Yin X, Gladstone R, Vittinghoff E, Vasan RS, Larson MG, Benjamin EJ, Marcus GM. Alcohol Consumption, Left Atrial Diameter, and Atrial Fibrillation. J Am Heart Assoc. 2016 Sep 14;5(9):e004060. doi: 10.1161/JAHA.116.004060.

  PMID: 27628571 BACKGROUND

• Mandyam MC, Vedantham V, Scheinman MM, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Gerstenfeld EP, Olgin JE, Marcus GM. Alcohol and vagal tone as triggers for paroxysmal atrial fibrillation. Am J Cardiol. 2012 Aug 1;110(3):364-8. doi: 10.1016/j.amjcard.2012.03.033. Epub 2012 Apr 20.

  PMID: 22521307 BACKGROUND

• Dukes JW, Dewland TA, Vittinghoff E, Olgin JE, Pletcher MJ, Hahn JA, Gladstone RA, Marcus GM. Access to alcohol and heart disease among patients in hospital: observational cohort study using differences in alcohol sales laws. BMJ. 2016 Jun 14;353:i2714. doi: 10.1136/bmj.i2714.

  PMID: 27301557 BACKGROUND

• Whitman IR, Agarwal V, Nah G, Dukes JW, Vittinghoff E, Dewland TA, Marcus GM. Alcohol Abuse and Cardiac Disease. J Am Coll Cardiol. 2017 Jan 3;69(1):13-24. doi: 10.1016/j.jacc.2016.10.048.

  PMID: 28057245 BACKGROUND

• Marcus GM, Smith LM, Whiteman D, Tseng ZH, Badhwar N, Lee BK, Lee RJ, Scheinman MM, Olgin JE. Alcohol intake is significantly associated with atrial flutter in patients under 60 years of age and a shorter right atrial effective refractory period. Pacing Clin Electrophysiol. 2008 Mar;31(3):266-72. doi: 10.1111/j.1540-8159.2008.00985.x.

  PMID: 18307620 BACKGROUND

• Groh CA, Faulkner M, Getabecha S, Taffe V, Nah G, Sigona K, McCall D, Hills MT, Sciarappa K, Pletcher MJ, Olgin JE, Marcus GM. Patient-reported triggers of paroxysmal atrial fibrillation. Heart Rhythm. 2019 Jul;16(7):996-1002. doi: 10.1016/j.hrthm.2019.01.027. Epub 2019 Feb 14.

  PMID: 30772533 BACKGROUND

• Marcus GM, Modrow MF, Schmid CH, Sigona K, Nah G, Yang J, Chu TC, Joyce S, Gettabecha S, Ogomori K, Yang V, Butcher X, Hills MT, McCall D, Sciarappa K, Sim I, Pletcher MJ, Olgin JE. Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation: The I-STOP-AFib Randomized Clinical Trial. JAMA Cardiol. 2022 Feb 1;7(2):167-174. doi: 10.1001/jamacardio.2021.5010.

  PMID: 34775507 BACKGROUND

• Marcus GM, Vittinghoff E, Whitman IR, Joyce S, Yang V, Nah G, Gerstenfeld EP, Moss JD, Lee RJ, Lee BK, Tseng ZH, Vedantham V, Olgin JE, Scheinman MM, Hsia H, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Fatch R, Hahn JA. Acute Consumption of Alcohol and Discrete Atrial Fibrillation Events. Ann Intern Med. 2021 Nov;174(11):1503-1509. doi: 10.7326/M21-0228. Epub 2021 Aug 31.

  PMID: 34461028 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Gregory Marcus, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregory M Marcus, MD, MAS

CONTACT

415-476-5706; greg.marcus@ucsf.edu

Hannah H Oo, BS

CONTACT

415-476-4999; hannah.oo@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, case-crossover trial.

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: April 17, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2029
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)