Alcohol as a Modifiable Risk Factor for Atrial Fibrillation

NCT07528729 | Not Yet Recruiting

• 1 other identifier: H-25013209
• Study Type: interventional
• Target: 414
• Locations: 0 countries
• Sites: N/A

Brief Summary

Atrial fibrillation (AF) is the most common arrhythmia, diagnosed in approximately 50 million people worldwide. Its prevalence is expected to increase, eventually affecting every third person, which will result in significant healthcare costs. AF symptoms include palpitations, shortness of breath, and fatigue. The condition may lead to discomfort from symptoms and medical treatment, reduced quality of life, and an increased risk of heart failure, stroke, and death. High alcohol intake can cause AF, trigger new episodes and worsen the condition. The aim of this project is to determine the effect of six months of alcohol abstinence after atrial fibrillation ablation, as modifiable risk factors have gained more attention in the prevention and treatment of AF. Secondly, this study will provide new insights into utilizing a technology platform that enables wearable devices to collect health data remotely. This approach makes ready-to-wear devices a simple and effective solution for monitoring patients' health from home. The study is designed as an open-label, pragmatic, prospective, 1:1 Randomized Controlled Trial (RCT) that will be preceded by a feasibility study (n=40) that will test the feasibility of the proposed inter-vention for the RCT study. The intervention consists of six months of alcohol abstinence after the ablation procedure. To ensure the best possible chance to succeed with complete alcohol absti-nence, the patients will be offered guidance and support from nurses at the hospital based on the techniques of motivational interviewing. After evaluating the outcomes of the feasibility study, appropriate adjustments will be made. All participants from the feasibility study will be included in the RCT study. The study will include a total of 414 participants. The feasibility will be evaluated in five main objec-tives according to the Medical Research Council guidance for designing and evaluating complex in-terventions: Recruitment, data collection, acceptability, resources spent and participant responses. The primary outcome of the RCT study is AF recurrence after 6 months measured with Withings Scanwatch 2. Secondary outcomes are Number of days with AF, change in AUDIT score, change in symptom burden (AFSS score), change in health-related quality of life (EQ-5D-5L), change in alcohol consumption (self-reported and Peth analysis), change in antiarrhythmic medicine and sick leave days. Part two of the study will investigate the long-term effect of alcohol abstinence after atrial fibrilla-tion ablation. Primary outcome is time to AF and secondary outcome is re-ablations, hospital admis-sions and antiarrhythmic therapy. Lastly, a cost-utility analysis will be performed.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation, atrial fibrillation ablation, risk factors, modifiable risk factor modification, alcohol, alcohol abstinence,

Outcome Measures

Primary Outcomes (2)

• Atrial fibrillation recurrence

  AF recurrence in the two groups, defined as incidences that last \>30 sec. from 3-6 months. There will be a 3-month blanking period as atrial fibrillation can occur in the first three months after the ablation procedure, even though it has been a successful treatment.

  6 months

• Time to atrial fibrillation (part two)

  We follow all patients until 1 year after including the last patient

  Up to 5 years

Secondary Outcomes (12)

• Number of days with AF

  3 to 6 months

• Symptom burden assessed with Atrial Fibrillation Severity Scale (AFSS) questionaire

  6 months

• Health Related Quality of Life meassured with the EQ-5D-5L self-reported questionnaire

  6 months

• Alcohol consumption

  6 months

• Fosfatidyletanol (PEth)

  3 weeks

Other Outcomes (8)

• Recruitment (feasibility)

  6 months

• Data collection - detection of at-risk drinking (feasibility)

  6 months

• Data collection - ECG's collected through smartwatch (feasibility)

  6 months

Study Arms (2)

Intervention

EXPERIMENTAL

Six months of alcohol abstinence after atrial fibrillation ablation treatment.

Behavioral: alcohol abstinence

Control group

NO INTERVENTION

The control group receives usual care (SOC) after atrial fibrillation ablation treatment. That means no focused nurse intervention and no restrictions regarding alcohol intake but will be advised according to existing guidelines.

Interventions

alcohol abstinence BEHAVIORAL

To ensure the best possible chance to succeed with complete alcohol abstinence, the patients will be offered guidance and support through nurse consultations, based on motivational interviewing. Each patient will be offered approximately 2-6 face-to-face/online/telephone consultations. Patients that score ≥20 on the Alcohol Use Disorder Identification Test (AUDIT) will be encouraged also to seek help from a alcohol addiction consultant.

Intervention

Eligibility Criteria

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

You may qualify if:

• All patients \>18 years old
• Referred to a first-time AF or AFL ablation
• Scores ≥3 on AUDIT/ ≥3 drinks per week
• Can use the ScanWatch2 as described

You may not qualify if:

• Patients who do not have a Danish social security number
• Patients who cannot read, and speak Danish fluently
• Unable to give informed consent.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

MeSH Terms

Conditions

Atrial Fibrillation; Alcohol Abstinence

Interventions

Ethanol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Central Study Contacts

Camilla N Bring, PhD student

CONTACT

+4535458869; camilla.nygaard.bring.01@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical nurse specialist and PhD student

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 14, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share