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Caffeine Consumption and Rate Control in Permanent Atrial FIBrillation: The CAFIB Trial

RecruitingPhase 2, Phase 3Ages 18 Years - 80 YearsAllHospital Universitario Getafe
NCT07738523 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The CAFIB trial is a multicenter, randomized, open-label, crossover clinical trial designed to determine whether habitual caffeine consumption in coffe adversely affects rate control in patients with permanent atrial fibrillation (AF). The rationale stems from the discrepancy between traditional clinical recommendations, which often advise patients with arrhythmias to avoid caffeine, and the growing body of evidence suggesting that moderate coffee consumption is not associated with an increased risk of AF and may even confer cardiovascular benefits. However, no randomized study has specifically investigated this issue in patients with permanent AF, a population in whom rate control remains the cornerstone of management. The primary hypothesis is that continued moderate caffeine consumption is non-inferior to caffeine abstinence regarding 24-hour mean heart rate control. Participants w

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years. * Permanent atrial fibrillation diagnosed for more than 3 months. * Stable rate-control status, defined as a resting heart rate \<110 bpm without changes in rate-control medication during the previous 2 months. * Habitual caffeine consumption (≥1 cup/day of caffeinated coffee). * Willingness to participate in the study, including acceptance of complete caffeine abstinence for up to two months if assigned to the abstinence arm. Exclusion Criteria: * Age \<18 years or \>80 years. * Previous diagnosis of cognitive impairment or dementia. * Legal incapacity or inability to provide informed consent. * Inability to understand or complete quality-of-life questionnaires. * Presence of a cardiac implantable electronic device with pacing capability (pacemaker, implantable cardioverter-defibrillator, or cardiac resynchronization therapy device). * Previous successful atrioventricular node ablation. * Decompensated heart failure (New York Heart Association class III-IV) or hospitalization for heart failure within the previous 3 months. * Acute coronary syndrome within the previous 3 months. * Stroke within the previous 3 months. * Cardiac surgery within the previous 3 months. * Severe unrepaired valvular heart disease.
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What it tests

  • Dietary Caffeine Intake
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Where

1 site
Getafe University Hospital
Getafe, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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