Clinical trial NCT06995391: Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
Official title: Digitally Rendered Interventions And Knowledge To Limit Ethanol-Associated Atrial Fibrillation Severity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Keywords: Atrial Fibrillation
AFib
Alcohol
Mediterranean Drinking Pattern
Red wine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2025-05-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single center, randomized, controlled, clinical trial, where subjects will be randomly assigned 1:1, stratified by recruitment blocks of 6 to one of two digital health interventions for one year.
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Change in atrial fibrillation severity at one year
timeFrame: From baseline to one year of study participation.
Secondary outcomes:
measure: Total number of negative urine ethyl glucuronide tests at one year
timeFrame: From baseline to one year of study participation.
measure: Results of the phosphatidylethanol test at one year
timeFrame: At one year of study participation.
measure: Atrial fibrillation burden at one year, quantified by Apple Watch
timeFrame: At one year of study participation.
measure: Atrial fibrillation burden at one year, quantified by a cardiac device
timeFrame: At one year of study participation.
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Medical Center at Parnassus
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gregory M Marcus, MD, MAS
role: PRINCIPAL_INVESTIGATOR
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