Menu
Recruiting NCT06754176

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

No phase Interventional Atrial Fibrillation (AF) Atrial Fibrillation (Paroxysmal)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Alcohol Consumption Randomized Instructions.
Who it may be relevant to
Registry conditions: Atrial Fibrillation (AF), Atrial Fibrillation (Paroxysmal). Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)

Overview

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.

Interventions

  • Behavioral Alcohol Consumption Randomized Instructions
    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.

Primary outcome measures

  • Presence or Absence of Discrete Atrial Fibrillation Episodes [Time frame: 2 weeks]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Other

Study locations

United States · 2 centers
  • UCSF Medical Center at Parnassus — San Francisco
  • UCSF Medical Center at Mission Bay — San Francisco

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 Wo PMID 34351783
  • 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 Strok PMID 32148086
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT06754176 · 24-41856 · R01AA022222

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗