Exploring the link between alcohol and atrial fibrillation recurrence: a multicentre randomised controlled trial (ETOH-AF)

Not Applicable

Completed

• Conditions: Atrial fibrillation; Atrial flutter; Alcohol abuse; Cardiomyopathy; Hypertension; Obstructive sleep apnoea; Cardiovascular - Other cardiovascular diseases; Public Health - Health promotion/education

• Registration Number: ACTRN12616000256471
• Lead Sponsor: Prof Peter Kistler

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-24
• Study Completion: 2018-08-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Paroxysmal AF (atrial fibrillation and/or flutter) with minimum 2 episodes in the last 6 months or persistent AF requiring direct cardioversion
- Average alcohol intake at least 10 standard drinks per week (120 g/week).

To be eligible for the sub-study (ABSTAIN-PVI), patients will need to have had a previous pulmonary vein isolation (AF ablation) procedure (in addition to the above criteria).

Exclusion Criteria

- Evidence of alcohol dependence (as determined by CAGE & AUDIT-C questionnaires)
- Presence of significant psychiatric comorbidity or cognitive impairment
- Permanent AF (where sinus rhythm cannot be restored)
- Advanced heart failure, as defined by left ventricular ejection fraction < 35%.
- Limited life expectancy (less than 24 months) due to co-morbid non-cardiac illness, including liver failure, end-stage renal disease or advanced malignancy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation / flutter (AF) burden - percentage of time spent in AF during the follow-up period (as assessed by either 3-monthly 7-day Holter monitor + symptom review with ECG, loop recorder or dual-chamber pacemaker).<br>[From start of intervention to 6 months later ];Time to first AF recurrence (by either Holter monitor, loop recorder, dual-chamber pacemaker, or ECG during symptoms)[Within the first 6 months from start of intervention (after a two week blanking period)]