Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity

Overview

Per the 2021 National Survey on Drug Use and Health administered by the U.S. Department of Health and Human Services, 85% of all American adults consume alcohol. Atrial fibrillation (AF) is the most common arrhythmia, affecting more than 10 million individuals in U.S., comprising 4.5% of the adult population. Although alcohol abstinence clearly reduces AF in heavy drinkers, observational data comparing the health effects of limited consumption versus abstention are conflicting. The Mediterranean diet is one of the few that has demonstrated clear cardiovascular benefits in a randomized study-this diet allows for the consumption of red wine (or high polyphenol/ low alcohol alcohol), generally not more than one drink in 24 hours, with meals, avoiding spirits and binge drinking. The effect of the "Mediterranean drinking pattern" on AF risk compared to alcohol abstinence remains unknown. This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. The knowledge gained from this study may be used to determine optimal thresholds for alcohol use among AF patients.

Detailed description

This single center, randomized, controlled trial aims to compare the effects of a digital health intervention to encourage durable alcohol abstinence versus allowing guideline-adherent moderate alcohol consumption on AF severity. Any English-speaking individual over the age of 21, with a diagnosis of paroxysmal or persistent AF, who consumes alcohol at least once per month and is willing to receive messaging encouraging alcohol abstinence, will be eligible to participate in this study.

Participants will be randomly assigned to one of two digital health interventions for one year. Those randomly assigned to the Contemporary Guideline-Adherence Arm will receive weekly app and text-based messaging encouraging them not to exceed guideline-directed amounts of alcohol, as well as messaging explaining that abstinence is acceptable and may be the best way to avoid AF and that, if a participant decides to consume alcohol, a Mediterranean drinking pattern may be the most healthy. Those randomly assigned to the Alcohol Abstinence Arm will receive weekly app- and text-based messaging encouraging avoidance of all alcohol consumption. Throughout the study, alcohol consumption (or abstinence) and atrial fibrillation episodes and severity will be assessed by serial surveys. Abstinence will also be objectively assessed via urine ethyl glucuronide (EtG) tests and a blood test for phosphatidylethanol (PEth) in randomly selected participants in each Arm. A minimum of 1,000 participants and up to 10,000 participants will be enrolled in the study.

Interventions

• Behavioral Contemporary Guideline-Adherence
  Participants randomized to Contemporary Guideline-Adherence will receive weekly app and text-based messaging encouraging them not to exceed guideline-directed amounts of alcohol, as well as messaging explaining that abstinence is acceptable and may be the best way to avoid AF and that, if a participant decides to consume alcohol, a Mediterranean drinking pattern may be the most healthy.
• Behavioral Alcohol Abstinence
  Participants randomized to Alcohol Abstinence will receive weekly app and text-based messaging encouraging avoiding all alcohol consumption.

Primary outcome measures

• Change in atrial fibrillation severity at one year [Time frame: From baseline to one year of study participation.]

Secondary outcome measures (4)

• Total number of negative urine ethyl glucuronide tests at one year [Time frame: From baseline to one year of study participation.]
• Results of the phosphatidylethanol test at one year [Time frame: At one year of study participation.]
• Atrial fibrillation burden at one year, quantified by Apple Watch [Time frame: At one year of study participation.]
• Atrial fibrillation burden at one year, quantified by a cardiac device [Time frame: At one year of study participation.]

Eligibility criteria

Inclusion criteria

• Are age 21 years or older
• Have a smartphone
• Are able to use the Eureka mobile application
• Have a history of paroxysmal or persistent atrial fibrillation (AF)
• Have consumed alcohol at least once per month on average in the past year
• Willing to receive messaging encouraging alcohol abstinence

Exclusion criteria

• Non-english speaker
• Currently pregnant or trying to get pregnant
• A healthcare professional's instruction to avoid alcohol (for any reason)
• Currently incarcerated
• Permanent AF (meaning a medical determination has been made that sinus rhythm would definitely never be pursued in this patient)
• Are unable to read or sign to provide informed consent

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

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• UCSF Medical Center at Parnassus — San Francisco

Publications

• Substance Abuse and Mental Health Services Administration, Results from the 2021 National Survey on Drug Use and Health: Summary of National Findings. 2021
• Gardner CD, Vadiveloo MK, Petersen KS, Anderson CAM, Springfield S, Van Horn L, Khera A, Lamendola C, Mayo SM, Joseph JJ; American Heart Association Council on Lifestyle and Cardiometabolic Health. Popular Dietary Patterns: Alignment With American Heart Association 2021 Dietary Guidance: A Scientific Statement From the American Heart Association. Circulation. 2023 May 30;147(22):1715-1730. doi: 10 PMID 37128940
• Gepner Y, Golan R, Harman-Boehm I, Henkin Y, Schwarzfuchs D, Shelef I, Durst R, Kovsan J, Bolotin A, Leitersdorf E, Shpitzen S, Balag S, Shemesh E, Witkow S, Tangi-Rosental O, Chassidim Y, Liberty IF, Sarusi B, Ben-Avraham S, Helander A, Ceglarek U, Stumvoll M, Bluher M, Thiery J, Rudich A, Stampfer MJ, Shai I. Effects of Initiating Moderate Alcohol Intake on Cardiometabolic Risk in Adults With Ty PMID 26458258
• Marfella R, Cacciapuoti F, Siniscalchi M, Sasso FC, Marchese F, Cinone F, Musacchio E, Marfella MA, Ruggiero L, Chiorazzo G, Liberti D, Chiorazzo G, Nicoletti GF, Sardu C, D'Andrea F, Ammendola C, Verza M, Coppola L. Effect of moderate red wine intake on cardiac prognosis after recent acute myocardial infarction of subjects with Type 2 diabetes mellitus. Diabet Med. 2006 Sep;23(9):974-81. doi: 10. PMID 16922703
• Ronksley PE, Brien SE, Turner BJ, Mukamal KJ, Ghali WA. Association of alcohol consumption with selected cardiovascular disease outcomes: a systematic review and meta-analysis. BMJ. 2011 Feb 22;342:d671. doi: 10.1136/bmj.d671. PMID 21343207
• 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
• Tu SJ, Gallagher C, Elliott AD, Linz D, Pitman BM, Hendriks JML, Lau DH, Sanders P, Wong CX. Risk Thresholds for Total and Beverage-Specific Alcohol Consumption and Incident Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Dec;7(12):1561-1569. doi: 10.1016/j.jacep.2021.05.013. Epub 2021 Jul 27. PMID 34330672
• 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

Identifiers

NCT: NCT06995391 · 24-41876 · R01AA022222

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗