Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF (PLATINUM)
Primary Purpose
Atrial Fibrillation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Study arm
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation focused on measuring Alcohol, AF, catheter ablation, recurrence
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Study
Control
Arm Description
Complete abstinence or ≤2 drinks/week in group 1 during the study period
Allowed to continue their pre-ablation drinking habit
Outcomes
Primary Outcome Measures
Arrhythmia recurrence
Arrhythmia recurrence across all AF types at 8 months after the ablation procedure, off- or on-antiarrhythmic drug (AAD)
Secondary Outcome Measures
Change in QoL
Change in QoL measured by AFEQT survey at baseline and 6 months
Change in cognitive function
Change in cognitive function measured by MoCA survey
Arrhythmia burden
Arrhythmia burden at follow-up
Full Information
NCT ID
NCT05510167
First Posted
August 15, 2022
Last Updated
August 18, 2022
Sponsor
Texas Cardiac Arrhythmia Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT05510167
Brief Title
Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF
Acronym
PLATINUM
Official Title
Impact of Post-ablation Alcohol Intake on Arrhythmia Recurrence, Quality of Life and Cognition in Patients With Atrial Fibrillation
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 22, 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Cardiac Arrhythmia Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
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.
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Alcohol, AF, catheter ablation, recurrence
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Paroxysmal and Persistent AF patients undergoing their first catheter ablation will be screened for eligibility and those that meet the criteria and consent to participate will be randomly assigned to group 1 or 2.
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
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study
Arm Type
Active Comparator
Arm Description
Complete abstinence or ≤2 drinks/week in group 1 during the study period
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Allowed to continue their pre-ablation drinking habit
Intervention Type
Behavioral
Intervention Name(s)
Study arm
Intervention Description
Participants will be asked to completely abstain from drinking or consume 2 or less drinks per week for 8 months following catheter ablation
Primary Outcome Measure Information:
Title
Arrhythmia recurrence
Description
Arrhythmia recurrence across all AF types at 8 months after the ablation procedure, off- or on-antiarrhythmic drug (AAD)
Time Frame
8 months after the ablation procedure for AF
Secondary Outcome Measure Information:
Title
Change in QoL
Description
Change in QoL measured by AFEQT survey at baseline and 6 months
Time Frame
6 months after the blanking period of 2 months
Title
Change in cognitive function
Description
Change in cognitive function measured by MoCA survey
Time Frame
6 months after the blanking period of 2 months
Title
Arrhythmia burden
Description
Arrhythmia burden at follow-up
Time Frame
6-8 months following ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Natale
Phone
5125448186
Email
dr.natale@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sanghamitra Mohanty
Phone
5127842651
Email
mitra1989@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Natale
Organizational Affiliation
Texas Cardiac Arrhythmia Institute, St.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF
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