Atrial Fibrillation (AF)FULL-PROOFNCT06754176
Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation
A study testing Alcohol Consumption Randomized Instructions in people with Atrial Fibrillation (AF) and Atrial Fibrillation (Paroxysmal), run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal)
- What is being tested?
- Alcohol Consumption Randomized Instructions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Apr 2025to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
UCSF Medical Center at Parnassus
San Francisco, California, 94143
Study Principal Investigator, 415-476-5706, greg.marcus@ucsf.edu
- Recruiting
UCSF Medical Center at Mission Bay
San Francisco, California, 94158
Study Principal Investigator, 415-476-5706, greg.marcus@ucsf.edu
About this study
Official title: Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
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?
Read more
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.
Read the detailed description
This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.
- Being tested
- Alcohol Consumption Randomized Instructions
- Keywords
- Alcohol, Drinking, Mediterranean Drinking Pattern, Atrial Fibrillation, AFib, AF, Heart Rhythm
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Consumption Randomized InstructionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Alcohol Consumption Randomized Instructions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (4)
As-Treated Relationships versus the Presence of AFib
As-treated (whether alcohol was consumed or not according to real-time patient reports using the Zio patch button and/ or alcohol sensors) relationships versus the presence of AFib will be considered.
Measured: 2 weeks
Daily Glucose Levels
This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a continuous glucose monitor that will record serum glucose levels. A secondary outcome will be difference in daily glucose levels due to alcohol consumption or avoidance during the monitoring period.
Measured: 2 weeks
Step Counts
This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a fitness tracker that will record step counts. A secondary outcome will be difference in step counts due to alcohol consumption or avoidance during the monitoring period.
Measured: 2 weeks
Sleep Duration
This will first be assessed according to intention-to-treat and then as-treated. Participants will be wearing a fitness tracker that will record sleep duration. A secondary outcome will be difference in sleep duration due to alcohol consumption or avoidance during the monitoring period.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2024
- Study start17 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, case-crossover trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Gregory Marcus, MD, MAS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754176
- Sponsor's protocol ID
- 24-41856
- Other IDs
- R01AA022222
- Acronym
- FULL-PROOF
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34351783Chung 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.
PubMed 32148086Voskoboinik 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.
PubMed 31893513Stewart 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.
PubMed 11602543Mukamal 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.
PubMed 16157768Mukamal 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.
PubMed 17239687Frost 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.
PubMed 15477433Djousse 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.
PubMed 15019874Engel 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.
PubMed 6826972Lowenstein 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.
PubMed 6625772Ettinger 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.
PubMed 636996Koskinen 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.
PubMed 3593617Marcus 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.
PubMed 33516710Aung 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.
PubMed 38037649McManus 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.
PubMed 27628571
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)
- ClinicalTrials.gov ID
- NCT06754176
- Acronym / sponsor ID
- FULL-PROOF / 24-41856
- Keywords
- Alcohol, Drinking, Mediterranean Drinking Pattern, Atrial Fibrillation, AFib, AF, Heart Rhythm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 17 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 31 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, case-crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Alcohol Non-Avoidance Case-Crossover Arm | Experimental | Behavioral: Alcohol Consumption Randomized InstructionsOn 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. |
| Alcohol Avoidance Case-Crossover Arm | Experimental | Behavioral: Alcohol Consumption Randomized InstructionsOn 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alcohol Consumption Randomized InstructionsAlcohol 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. | Behavioural | Alcohol Avoidance Case-Crossover Arm, Alcohol Non-Avoidance Case-Crossover Arm |
Primary outcome
Presence or Absence of Discrete Atrial Fibrillation Episodes
Time frame: 2 weeks
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.
4 secondary outcomes
As-Treated Relationships versus the Presence of AFib
Time frame: 2 weeks
Daily Glucose Levels
Time frame: 2 weeks
Step Counts
Time frame: 2 weeks
Sleep Duration
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Background: PubMed 34351783Benjamin 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.
- Background: PubMed 32148086Chung 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.
- Background: PubMed 31893513Voskoboinik 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.
- Background: PubMed 11602543Stewart 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.
- Background: PubMed 16157768Mukamal 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.
- Background: PubMed 17239687Mukamal 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.
- Background: PubMed 15477433Frost 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.
- Background: PubMed 15019874Djousse 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.
- Background: PubMed 6826972Engel 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.
- Background: PubMed 6625772Lowenstein 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.
- Background: PubMed 636996Ettinger 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.
- Background: PubMed 3593617Koskinen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregory Marcus, MD, MAS principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Consumption Randomized Instructions in people with Atrial Fibrillation (AF) and Atrial Fibrillation (Paroxysmal), run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory M Marcus, MD, MAS (415-476-5706, greg.marcus@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or Absence of Discrete Atrial Fibrillation Episodes (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06754176, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.