Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF (PLATINUM)

Impact of Post-ablation Alcohol Intake on Arrhythmia Recurrence, Quality of Life and Cognition in Patients With Atrial Fibrillation

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Behavioral: Study arm

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

• Study Type: Interventional
• Enrollment (Anticipated): 130
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Natale; Phone Number: 5125448186; Email: dr.natale@gmail.com
• Study Contact Backup: Name: Sanghamitra Mohanty; Phone Number: 5127842651; Email: mitra1989@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• AF patients that regularly consume >5 alcoholic drink (*12 g of pure alcohol/drink)/week
• Paroxysmal or persistent AF
• First catheter ablation History of alcohol-induced arrhythmia
• Willing to sign the written informed consent

Exclusion Criteria:

• Binge drinkers (alcohol dependence)
• Non-drinkers
• LVEF <35%
• Psychiatric conditions
• MoCA score ≤ 17 on Montreal Cognitive Assessment (MoCA)
• Patients with established dementia
• Medically unstable patients (acute/unstable or poorly controlled problems that would demand focused, relatively urgent or emergent medical attention)
• Unwilling for alcohol-abstinence
• Long-standing persistence AF
• Patient under legal protection
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Study; Complete abstinence or ≤2 drinks/week in group 1 during the study period	Behavioral: Study arm; Participants will be asked to completely abstain from drinking or consume 2 or less drinks per week for 8 months following catheter ablation
ACTIVE_COMPARATOR: Control; Allowed to continue their pre-ablation drinking habit	Behavioral: Study arm; Participants will be asked to completely abstain from drinking or consume 2 or less drinks per week for 8 months following catheter ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arrhythmia recurrence	Arrhythmia recurrence across all AF types at 8 months after the ablation procedure, off- or on-antiarrhythmic drug (AAD)	8 months after the ablation procedure for AF

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in QoL	Change in QoL measured by AFEQT survey at baseline and 6 months	6 months after the blanking period of 2 months
Change in cognitive function	Change in cognitive function measured by MoCA survey	6 months after the blanking period of 2 months
Arrhythmia burden	Arrhythmia burden at follow-up	6-8 months following ablation

Collaborators and Investigators

• Sponsor: Texas Cardiac Arrhythmia Research Foundation
• Investigators: Principal Investigator: Andrea Natale, Texas Cardiac Arrhythmia Institute, St.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): August 22, 2022
• Primary Completion (ANTICIPATED): August 1, 2024
• Study Completion (ANTICIPATED): August 1, 2025

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (ACTUAL): August 22, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 18, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Alcohol; recurrence; catheter ablation; AF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: TCAI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No