None listed
Conditions
Brief summary
ETOH-AF trial: While the association between binge drinking and atrial tachyarrhythmias is well-established, even moderate alcohol consumption has recently been identified as a significant risk factor for atrial fibrillation and/or flutter (AF) in a dose-dependent manner. To date, there have been no randomised-controlled trials looking at the impact of alcohol abstinence on AF outcomes. Moreover, we are keen to look at the overall effects of alcohol abstinence on other cardiovascular outcomes (inc. blood pressure, cardiac structure and function, sleep apnoea) and non-cardiovascular outcomes (inc. quality of life, mood). We hypothesise that alcohol abstinence will reduce AF recurrences, AF burden, AF symptoms and AF hospitalisations, as well as resulting in reductions in LV size, LA size, sleep apnoea parameters and blood pressure, and improvements in LA & LV function, mood and quality of life. We intend to recruit at least 140 patients and randomise them to either an alcohol Abstinence or Control arm, and follow them up for 12 months (with a 1 month run-in phase prior). Alcohol consumption in both arms will be monitored using weekly alcohol diaries, urine ETG (pending funding) and blood tests (inc. MCV, GGT). Monitoring for AF recurrences will occur by either: (i) Insertion of an implantable loop recorder OR (ii) Wearing a 7-day Holter monitor every 3 months +/- ECG transmission using the AliveECG smartphone app (if available) +/- ECG during symptoms of AF (iii) Interrogation of permanent pacemakers/defibrillators every 3 months in those with pre-existing dual chamber devices. Baseline and follow-up data collected includes: 12-lead ECG - 0 and 12 months. Blood pressure and weight - 0,3,6,9,12 months. Sleep study - 0 and 12 months. Basic bloods (lipids, glucose, FBE, UEC, LFT, BNP) - 0,6,12 months. Transthoracic echocardiogram (inc. LV size & EF, LA size, LA strain) - 0 and 12 months. AF symptom severity questionnaire (AFSS) & Medical questionnaire - 0,3,6,9,12 months. Mood & quality of life questionnaires - 0 & 12 months. Cardiac MRI substudy (pending funding) - 0 and 6-12 months. We will also be looking at a subgroup of patients who have had a previous pulmonary vein isolation (ABSTAIN-PVI substudy) to determine whether alcohol abstinence is beneficial in this sub-population. The trial protocol is unchanged (inc. outcomes) for these patients.
Interventions
Alcohol abstinence: All patients in this arm will be encouraged and counselled to abstain completely from all forms of alcohol for a 12-month period. They will have a one-on-one 15-minute session with a specialist physician at 0,3,6,9 and 12 months, as would occur in routine clinical practice (note patients with alcohol dependence are excluded from the study). Attendance will be recorded. They will be provided written advice and links to online resources to assist them. Patients with initial dif
Alcohol abstinence: All patients in this arm will be encouraged and counselled to abstain completely from all forms of alcohol for a 12-month period. They will have a one-on-one 15-minute session with a specialist physician at 0,3,6,9 and 12 months, as would occur in routine clinical practice (note patients with alcohol dependence are excluded from the study). Attendance will be recorded. They will be provided written advice and links to online resources to assist them. Patients with initial difficulty in abstaining from alcohol will be referred to a clinician with specialized expertise in alcohol-related counselling, brief intervention and anti-craving therapy. Compliance will be monitored by weekly alcohol consumption diaries, weekly phone calls, as well as random urine testing for alcohol metabolites (urine ETG, pending funding). Patients in both arms will have a 1 month run-in phase prior to being formally randomized - they will be required to submit weekly alcohol diaries. This will assess their compliance and also ensure they meet the inclusion criteria for alcohol intake.
Sponsors
Prof Peter Kistler
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Outcome results
None listed