Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-01 @ 4:40 AM
Study NCT ID:
NCT05510167
Status:
UNKNOWN
Last Update Posted:
2022-08-22
First Post:
2022-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF
Sponsor:
Texas Cardiac Arrhythmia Research Foundation
Organization:
Study Overview
Official Title:
Impact of Post-ablation Alcohol Intake on Arrhythmia Recurrence, Quality of Life and Cognition in Patients With Atrial Fibrillation
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PLATINUM
Brief 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.
Detailed 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: