Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation

Официальное название

Full-Avoidance vs. Permissive/Regulated Drinking & Outcomes On Fibrillation (FULL-PROOF)

Обзор

The goal of this study is to assess the short-term effects of minimal and moderate drinking on atrial fibrillation (AFib) episodes in a real-world population diagnosed with 'come-and-go'/paroxysmal AFib. The question it aims to answer is: Is there a greater occurrence of AFib episodes when participants are allowed to consume alcohol according to random assignment? Participants will: * Be given daily random assignments to avoid or not to avoid alcohol * Wear an adhesive electrocardiographic (ECG) heart monitor * Wear a wrist-worn fitness tracker * Wear an anklet transdermal alcohol monitor * Wear an adhesive glucose monitor * Complete morning and evening surveys daily Participants may be compensated up to $50 for full completion of the study. This study can be done in-person or remote.

Подробное описание

This study is a case-crossover randomized trial, where each participant will be instructed to avoid or not avoid drinking alcohol on randomly assigned days during a 14-day monitoring period. Participants will also wear an external ECG monitor, an alcohol monitor, a continuous glucose monitor, and a fitness tracker for up to two weeks while utilizing a mobile application to receive daily instructions/reminders on drinking and short surveys. The investigators will compare participant self-report of alcohol consumption, glucose monitoring, fitness levels, sleep health, and heart rhythm data in order to better understand the immediate relationship between drinking alcohol and heart rhythm. A total of 100 participants will be enrolled.

Вмешательства

• Поведенческое Alcohol Consumption Randomized Instructions
  Alcohol Avoidance: In this intervention assignment, participants will be instructed to avoid drinking alcohol for this day. Alcohol Non-Avoidance: In this intervention assignment, participants will be allowed to drink alcohol for this day.

Первичные конечные точки

• Presence or Absence of Discrete Atrial Fibrillation Episodes [Срок оценки: 2 weeks]

Вторичные конечные точки (4)

• As-Treated Relationships versus the Presence of AFib [Срок оценки: 2 weeks]
• Daily Glucose Levels [Срок оценки: 2 weeks]
• Step Counts [Срок оценки: 2 weeks]
• Sleep Duration [Срок оценки: 2 weeks]

Критерии участия

Критерии включения

• Comfortable reading and writing in English
• Have a smartphone and willing and able to use the Eureka mobile application
• Currently diagnosed with paroxysmal AFib without a plan to change their AFib management during the two-week monitoring period
• At least one episode of AFib in the past month OR, in the judgement of a healthcare provider, could potentially have one episode of AF in the next month
• Drank alcohol at least 1 day/week on average in the past month
• Willing and able to be randomly assigned daily to avoid or not avoid drinking alcohol over a 2-week period
• Willing and able to provide written informed consent

Критерии исключения

• Only post-operative AFib
• Greater than 40% ventricular pacing
• History of alcohol addiction or abuse determined by self-reported history or AUDIT-C score
• Intolerance to alcohol
• History of liver disease
• Currently incarcerated
• Currently pregnant or trying to get pregnant

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

США · 2 центра

• UCSF Medical Center at Parnassus — San Francisco
• UCSF Medical Center at Mission Bay — San Francisco

Публикации

• Benjamin EJ, Al-Khatib SM, Desvigne-Nickens P, Alonso A, Djousse L, Forman DE, Gillis AM, Hendriks JML, Hills MT, Kirchhof P, Link MS, Marcus GM, Mehra R, Murray KT, Parkash R, Pina IL, Redline S, Rienstra M, Sanders P, Somers VK, Van Wagoner DR, Wang PJ, Cooper LS, Go AS. Research Priorities in the Secondary Prevention of Atrial Fibrillation: A National Heart, Lung, and Blood Institute Virtual Wo PMID 34351783
• Chung MK, Eckhardt LL, Chen LY, Ahmed HM, Gopinathannair R, Joglar JA, Noseworthy PA, Pack QR, Sanders P, Trulock KM; American Heart Association Electrocardiography and Arrhythmias Committee and Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Strok PMID 32148086
• Voskoboinik A, Kalman JM, De Silva A, Nicholls T, Costello B, Nanayakkara S, Prabhu S, Stub D, Azzopardi S, Vizi D, Wong G, Nalliah C, Sugumar H, Wong M, Kotschet E, Kaye D, Taylor AJ, Kistler PM. Alcohol Abstinence in Drinkers with Atrial Fibrillation. N Engl J Med. 2020 Jan 2;382(1):20-28. doi: 10.1056/NEJMoa1817591. PMID 31893513
• Stewart S, Hart CL, Hole DJ, McMurray JJ. Population prevalence, incidence, and predictors of atrial fibrillation in the Renfrew/Paisley study. Heart. 2001 Nov;86(5):516-21. doi: 10.1136/heart.86.5.516. PMID 11602543
• Mukamal KJ, Tolstrup JS, Friberg J, Jensen G, Gronbaek M. Alcohol consumption and risk of atrial fibrillation in men and women: the Copenhagen City Heart Study. Circulation. 2005 Sep 20;112(12):1736-42. doi: 10.1161/CIRCULATIONAHA.105.547844. Epub 2005 Sep 12. PMID 16157768
• Mukamal KJ, Psaty BM, Rautaharju PM, Furberg CD, Kuller LH, Mittleman MA, Gottdiener JS, Siscovick DS. Alcohol consumption and risk and prognosis of atrial fibrillation among older adults: the Cardiovascular Health Study. Am Heart J. 2007 Feb;153(2):260-6. doi: 10.1016/j.ahj.2006.10.039. PMID 17239687
• Frost L, Vestergaard P. Alcohol and risk of atrial fibrillation or flutter: a cohort study. Arch Intern Med. 2004 Oct 11;164(18):1993-8. doi: 10.1001/archinte.164.18.1993. PMID 15477433
• Djousse L, Levy D, Benjamin EJ, Blease SJ, Russ A, Larson MG, Massaro JM, D'Agostino RB, Wolf PA, Ellison RC. Long-term alcohol consumption and the risk of atrial fibrillation in the Framingham Study. Am J Cardiol. 2004 Mar 15;93(6):710-3. doi: 10.1016/j.amjcard.2003.12.004. PMID 15019874

Идентификаторы

NCT: NCT06754176 · 24-41856 · R01AA022222

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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