Alcohol as a Modifiable Risk Factor for Atrial Fibrillation

ConditionAtrial Fibrillation (AF)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorRigshospitalet, Denmark

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who do not have a Danish social security number

Patients who cannot read, and speak Danish fluently

Unable to give informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

414 Participants

are divided into 2 treatment groups

Group A: InterventionExperimental treatment 1 intervention

Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame

6 months

Time to atrial fibrillation (part two)

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

Time frame

Up to 5 years

Secondary outcomes

Number of days with AF

defined as incidences that last \>30 sec.

Time frame

3 to 6 months

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

The AFSS questionnaire is a validated patient-reported outcome measure used to assess the severity and impact of AF. The AFSS evaluates four domaines: burden, helath care utilization, symptoms and global well-being. Scores range from 3-30, with higher scores indicating greater AF severity and symptom burden.

Time frame

6 months

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

The EQ-5D-5L is a validated patient-reported questionnaire assessing health-related quality of life across five domains: mobility, self-care, ususal activities , pain/discomfort, and anxiety/depression. Responses are converted into a single index score reflecting overall health status, with higher scores indicating better health-related quality of life. The questionnaire also includes a visual analogue scale ranging from 0-100, where higher scores indicate better perceived health.

Time frame

6 months

Alcohol consumption

Alcohol consumption is measured as grams per week according to their alcohol log. It is measured at baseline and at 6 months, using the Timeline follow-back method recalling alcohol consumption 2 weeks prior inclusion and 2 weeks prior outcome assesment. Intervention group will also asked about alcohol consumption at intervention consultations.

Time frame

6 months

Other outcomes

Recruitment (feasibility)

The recruitment rate will be evaluated, and the feasibility will be measured as a percent of the total patient population estimated to be in the target group. The criteria are supported if 80% of the total patient population is deemed acceptable for inclusion.

Time frame

6 months

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

The data collection method will be evaluated to see: 1\. If it is suitable and feasible to detect patients with at-risk drinking. The criterion is supported if 75 % of the total patient population answer the AUDIT questionnaire.

Time frame

6 months

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

The data collection method will be evaluated to see: If it is achievable to receive ECG from a smartwatch once a day, and when the patients ex-perience symptoms (at the beginning and end of symptoms). The criterion is supported if we receive 80 % of the ECG's during the feasibility period.

Time frame

6 months

Data collection - monitoring activity level with smartwatch (feasibility)

The criterion will be evaluated to see if it is possible to monitor patients' activity level with the use of a smartwatch. This will be evaluated based on patients' feedback regarding using the smartwatch continuously during the feasibility period.

Time frame

6 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov

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