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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12616000256471
Ethics application status
Approved
Date submitted
22/02/2016
Date registered
24/02/2016
Date last updated
6/09/2019
Date data sharing statement initially provided
8/11/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Exploring the link between alcohol and atrial fibrillation recurrence: a multicentre randomised controlled trial (ETOH-AF)
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Scientific title
Exploring the link between alcohol and atrial fibrillation recurrence: a multicentre randomised controlled trial (ETOH-AF)
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Secondary ID [1]
288588
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Nil known
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Universal Trial Number (UTN)
U1111-1179-9127
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Trial acronym
ETOH-AF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial fibrillation
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Atrial flutter
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Alcohol abuse
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Cardiomyopathy
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Hypertension
297729
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Obstructive sleep apnoea
297730
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Condition category
Condition code
Cardiovascular
297912
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0
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Other cardiovascular diseases
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Public Health
297913
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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.
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Intervention code [1]
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Lifestyle
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Intervention code [2]
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Treatment: Other
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Intervention code [3]
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Prevention
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Comparator / control treatment
Control arm: Patients in this control group will be advised they can continue their usual alcohol consumption. However, they will be provided written & verbal information about recommended safe levels of drinking and encouraged to have regular follow-up with their usual treating clinician.
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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
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Timepoint [1]
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From start of intervention to 6 months later
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Primary outcome [2]
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Time to first AF recurrence (by either Holter monitor, loop recorder, dual-chamber pacemaker, or ECG during symptoms)
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Assessment method [2]
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Timepoint [2]
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Within the first 6 months from start of intervention (after a two week blanking period)
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Secondary outcome [1]
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Hospitalisations for AF (by review of medical records and ECGs during hospitalisation)
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Assessment method [1]
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Timepoint [1]
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Within the first 6 months from start of intervention.
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Secondary outcome [2]
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Blood pressure (over brachial artery, measured by sphygmomanometer)
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Assessment method [2]
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Timepoint [2]
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At 0 and 6 months.
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Secondary outcome [3]
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Weight (measured by digital scales)
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Assessment method [3]
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Timepoint [3]
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At 0 and 6 months.
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Secondary outcome [4]
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Quality of life, as assessed by SF-36 Quality of Life Questionnaire
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Assessment method [4]
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Timepoint [4]
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At 0 and 6 months.
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Secondary outcome [5]
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Depression, as assessed by % with Beck depression score > 10
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Assessment method [5]
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Timepoint [5]
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At 0 and 6 months.
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Secondary outcome [6]
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Cardiac MRI LV end-diastolic volume index (LVEDVI) (optional sub study, pending funding)
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Assessment method [6]
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Timepoint [6]
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0 and 6 months
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Secondary outcome [7]
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Number of AF recurrences (as measured by either Holter monitor, loop recorder, dual-chamber pacemaker, or ECG during symptoms)
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Assessment method [7]
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Timepoint [7]
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In first 6 months from start of intervention.
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Secondary outcome [8]
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Cardiac MRI LV mass index (optional sub study, pending funding)
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Assessment method [8]
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Timepoint [8]
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0 and 6 months
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Secondary outcome [9]
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Cardiac MRI LV ejection fraction (optional sub study, pending funding)
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Assessment method [9]
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Timepoint [9]
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0 and 6 months
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Secondary outcome [10]
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Cardiac MRI LV tissue characterisation (optional sub study, pending funding) using T1 mapping, STIR, late Gadolinium enhancement
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Assessment method [10]
321107
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Timepoint [10]
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0 and 6 months
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Secondary outcome [11]
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Cardiac MRI left atrial function - using strain, LA ejection fraction, LA passive emptying fraction (optional sub study, pending funding)
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Assessment method [11]
321108
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Timepoint [11]
321108
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0 and 6 months
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Secondary outcome [12]
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Cardiac MRI left atrial volume (optional sub study, pending funding)
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Assessment method [12]
321109
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Timepoint [12]
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0 and 6 months
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Secondary outcome [13]
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Cardiac MRI left atrial tissue characterisation with T1 mapping (optional sub study, pending funding)
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Assessment method [13]
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Timepoint [13]
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0 and 6 months
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Secondary outcome [14]
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Cardiac MRI left atrial area (optional sub study, pending funding)
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Assessment method [14]
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Timepoint [14]
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0 and 6 months
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Secondary outcome [15]
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Change in AF burden – comparison between 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) and baseline burden
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Assessment method [15]
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Timepoint [15]
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Comparison between 0 & 6 months
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Secondary outcome [16]
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European Heart Rhythm Association (EHRA) score for AF-related symptoms
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Assessment method [16]
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Timepoint [16]
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0 and 6 months
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Eligibility
Key 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).
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Minimum age
18
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
There will be initial concealment of allocation from study investigators (using central randomisation by a computer)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
For ETOH-AF, the sample size calculation for the primary endpoint of time to AF recurrence assumes an annual recurrence rate of 30% based on preliminary data. To detect a minimum absolute difference in recurrence of 20% between groups, we will need to enrol 70 patients in each group to provide a power of 0.8 at an alpha value of 0.05.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2016
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Actual
7/03/2016
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Date of last participant enrolment
Anticipated
2/04/2018
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Actual
20/02/2018
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Date of last data collection
Anticipated
20/08/2018
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Actual
20/08/2018
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Sample size
Target
140
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Accrual to date
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Final
140
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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The Alfred - Prahran
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Recruitment hospital [2]
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Royal Melbourne Hospital - City campus - Parkville
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Recruitment hospital [3]
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Monash Medical Centre - Clayton campus - Clayton
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Recruitment hospital [4]
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Western Hospital - Footscray
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Recruitment hospital [5]
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Sunshine Hospital - St Albans
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Recruitment hospital [6]
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Cabrini Hospital - Malvern - Malvern
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Recruitment hospital [7]
5313
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Melbourne Private Hospital - Parkville
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Recruitment hospital [8]
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
12777
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3011 - Footscray
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Recruitment postcode(s) [2]
12778
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3020 - Sunshine
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Recruitment postcode(s) [3]
12775
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3052 - Parkville
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Recruitment postcode(s) [4]
12776
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3084 - Heidelberg
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Recruitment postcode(s) [5]
12779
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3144 - Malvern
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Recruitment postcode(s) [6]
12774
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3168 - Clayton
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Recruitment postcode(s) [7]
12773
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3181 - Prahran
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Prof Peter Kistler
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Address [1]
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Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Prof Peter Kistler
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Address
Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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Country
Australia
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Secondary sponsor category [1]
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Individual
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Name [1]
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Dr Aleksandr Voskoboinik
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Address [1]
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Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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Country [1]
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Prof Jonathan Kalman
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Address [1]
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Department of Cardiology, Royal Melbourne Hospital, Grattan St, Parkville, Vic, 3052
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Country [1]
278843
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Dr Emily Kotschet
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Address [2]
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Department of Cardiology, Monash Medical Centre, Clayton Rd, Clayton, Vic, 3168
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Country [2]
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Australia
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Other collaborator category [3]
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Individual
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Name [3]
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Dr Michael Wong
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Address [3]
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Department of Cardiology, Western Hospital, Gordon St, Footscray, Vic, 3011
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Country [3]
278845
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Australia
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Other collaborator category [4]
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Individual
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Name [4]
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A/Prof Omar Farouque
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Address [4]
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Department of Cardiology, Austin Hospital, Studley Rd, Heidelberg, Vic, 3084
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Country [4]
278846
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
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Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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17/12/2015
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Approval date [1]
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08/01/2016
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Ethics approval number [1]
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HREC/15/Alfred/84
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Summary
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.
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Trial website
N/A
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Trial related presentations / publications
Nil to date
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Public notes
If you have atrial fibrillation or flutter and consume more than 10 drinks of alcohol per week, and are keen to enrol in a trial looking at the effects of alcohol abstinence, please email etoh.af@gmail.com
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Contacts
Principal investigator
Name
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Prof Peter Kistler
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Address
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Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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Country
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Australia
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Phone
63722
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+61 3 8532 1427
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Fax
63722
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Email
63722
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peter.kistler@bakeridi.edu.au
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Contact person for public queries
Name
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Aleksandr Voskoboinik
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Address
63723
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Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic, 3181
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Country
63723
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Australia
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Phone
63723
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+61 3 90762000
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Fax
63723
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+61 3 80800747
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Email
63723
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a.voskoboinik@alfred.org.au
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Contact person for scientific queries
Name
63724
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Aleksandr Voskoboinik
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Address
63724
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Heart Centre, Alfred Hospital, Commercial Rd, Prahran, Vic.
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Country
63724
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Australia
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Phone
63724
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+61 3 90762000
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Fax
63724
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+61 3 80800747
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Email
63724
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a.voskoboinik@alfred.org.au
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Spreadsheet of de-identified data with primary and secondary endpoints
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When will data be available (start and end dates)?
From 1st January 2020 until 1st January 2022
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Available to whom?
Researchers with a suitable research plan / proposal.
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Available for what types of analyses?
Meta-analyses and systematic reviews
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How or where can data be obtained?
By contacting Dr Voskoboinik - email: a.voskoboinik@alfred.org.au
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Alcohol Abstinence in Drinkers with Atrial Fibrillation.
2020
https://dx.doi.org/10.1056/NEJMoa1817591
N.B. These documents automatically identified may not have been verified by the study sponsor.
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