Actively Recruiting
Effects of Regular Coffee Consumption Versus Caffeine Abstinence on Heart Rate Control in Adults with Permanent Atrial Fibrillation in a Randomized Crossover Study
Led by Hospital Universitario Getafe · Updated on 2026-07-31
50
Participants Needed
1
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of regular caffeine consumption versus caffeine abstinence on heart rate control in adults with permanent atrial fibrillation AF. The CAFIB trial is a multicenter, randomized, open-label crossover study designed to understand if moderate habitual caffeine intake affects heart rate management in this population, considering that traditional advice often recommends avoiding caffeine despite growing evidence suggesting moderate coffee consumption may not worsen AF and might offer cardiovascular benefits. Participants will be randomly assigned to one of two groups continuing their usual caffeinated coffee intake at least one cup daily or complete caffeine abstinence while allowing decaffeinated coffee. Energy drinks are prohibited for both groups. The study has no washout period between crossover phases due to caffeines short biological half-life. Adherence to caffeine intake or abstinence will be monitored through diaries and interviews during the study. Participants will attend three scheduled visits over 60 days at baseline, 30 days, and 60 days. Each visit includes clinical assessments, ECG, 24-hour Holter monitoring to measure heart rate, blood sampling, and quality-of-life questionnaires. The primary outcome is the 24-hour mean heart rate. Secondary outcomes include changes in heart rate, symptom severity, quality of life, heart failure biomarkers, adverse events, and medication changes. The study aims to recruit 50 patients and includes careful statistical analysis to assess the impact of caffeine on heart rate control.
CONDITIONS
Brief Title
Caffeine Consumption and Rate Control in Permanent Atrial FIBrillation: The CAFIB Trial
Research Team
M
Martín Negreira-Caamaño, MD, PhD
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here