Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05510167 |
| Other study ID # |
TCAI |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 22, 2022 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
August 2022 |
| Source |
Texas Cardiac Arrhythmia Research Foundation |
| Contact |
Andrea Natale |
| Phone |
5125448186 |
| Email |
dr.natale[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Earlier studies have shown a dose-dependent relationship between alcohol intake and incident
atrial fibrillation (AF) as well as a causal link with several risk factors for AF such as
hypertension, obesity and sleep apnea. However, the effect of drinking (alcohol) on
post-ablation outcome such as arrhythmia recurrence, quality of life (QoL) and cognitive
function in AF patients is unclear. Therefore, we aim to find the answer for a very
frequently asked question, "is it safe to continue drinking alcohol (at the pre-ablation
level) following catheter ablation OR should the intake be reduced for better outcome?", in
this randomized trial.
Description:
1. BACKGROUND Earlier studies have not only reported alcohol-abstinence to be associated
with lower recurrence of AF in patients receiving non-ablative antiarrhythmic therapy,
but also unfavorable outcome among regular drinkers (high frequency and quantity)
compared to non-drinkers undergoing AF ablation (1-3). In a meta-analysis of 14 studies,
where the effect measures for AF associated with highest vs lowest alcohol intake were
pooled for analysis, not consuming alcohol was observed to be the most favorable in
terms of AF risk reduction (4). Larsson et al reported alcohol drinking, even in
moderate quantity, to be a risk factor for incident AF, whereas Zhang et al observed
moderate drinking to be associated with high AF risk in men only and not in females (5,
6). Moreover, a causal link between alcohol intake and other cardiovascular morbidities
such as obesity, hypertension, left ventricular dysfunction and sleep apnea that are
known risk factors for AF has been documented by several studies (1). Thus, we know that
alcohol consumption, even in moderate quantity, increases the risk for AF, although may
not be across genders. Observational studies also have shown unfavorable procedure
outcome to be more common in drinkers compared to non-drinkers receiving AF ablation.
However, there is no randomized data to support the latter statement. Additionally,
there are no data on the influence of alcohol intake on the cognitive function and QoL
in AF patients receiving catheter ablation. Therefore, this investigator-initiated,
randomized trial has been designed to examine the impact of alcohol intake vs abstinence
on arrhythmia recurrence and burden, QoL and cognitive function in regular drinkers
undergoing their first catheter ablation.
2. STUDY RATIONALE We hypothesize that alcohol-abstinence will significantly improve the
procedural outcome, QoL and cognitive function in the study population compared to the
non-abstinence cohort.
3. STUDY OBJECTIVES Primary Objective Arrhythmia recurrence across all AF types at 8 months
after the ablation procedure, off- or on-antiarrhythmic drug (AAD) Secondary Objective
1) Change in QoL score measured by AFEQT survey at baseline and 6 months 2) Change in
cognitive function measured by MoCA survey 3) Arrhythmia burden at follow-up
Study period will start from the day after the procedure and continue for 8 months (2-month
blanking period+ 6 months follow-up).
Group 1: Complete abstinence or ≤2 drinks/week in group 1 during the study period Group 2:
Allowed to continue their pre-ablation drinking habit
