Caffeine and Heart-Rate Control in Permanent Atrial Fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

CAFIB is a multicenter, randomized, open-label, crossover study asking if habitual caffeine consumption can be continued without worsening 24-hour heart-rate control in adults with permanent atrial fibrillation. Participants will alternate between periods of normal caffeine intake and caffeine abstinence to compare effects on resting and 24-hour heart rate. The study aims to determine non-inferiority of caffeine use versus abstinence for rate control while monitoring safety and quality of life. The trial builds on observational data suggesting coffee may not raise AF risk and could offer cardiovascular benefits, but addresses this question specifically in permanent AF. Key eligibility includes confirmed permanent AF for at least 3 months, stable rate control, and habitual caffeine use.

Why it matters

Who can join: the full rules

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.

Where it's running

• Getafe University Hospital
  Getafe, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Martín Negreira-Caamaño, MD, PhD
• Email: martin.negcam@gmail.com
• Phone: +34 916839360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.