NCT05510167 Post-ablation Alcohol Impacts Arrhythmia Recurrence, Quality of Life and Cognition in AF
| NCT ID | NCT05510167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Texas Cardiac Arrhythmia Research Foundation |
| Condition | Atrial Fibrillation |
| Study Type | INTERVENTIONAL |
| Enrollment | 184 participants |
| Start Date | 2022-08-22 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 184 participants in total. It began in 2022-08-22 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Andrea Natale
PRINCIPAL INVESTIGATOR
Texas Cardiac Arrhythmia Institute, St.
Frequently Asked Questions
Who can join the NCT05510167 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Fibrillation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05510167 currently recruiting?
Yes, NCT05510167 is actively recruiting participants. Contact the research team at dr.natale@gmail.com for enrollment information.
Where is the NCT05510167 trial being conducted?
This trial is being conducted at Austin, United States.
Who is sponsoring the NCT05510167 clinical trial?
NCT05510167 is sponsored by Texas Cardiac Arrhythmia Research Foundation. The principal investigator is Andrea Natale at Texas Cardiac Arrhythmia Institute, St.. The trial plans to enroll 184 participants.
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