Preprint · Jan 31, 2026
Atrial Fibrillation and frailty development in older patients. Do therapeutic options exert a protective effect? The CAFFE Study protocol (Preprint)
By Berni E, De Angelis V, Santamaria E et al.
BACKGROUND Atrial fibrillation (AF), an arrhythmia highly prevalent in older individuals, is associated with frailty and disability. AF therapy is based on rhythm-control (RhythmC), to restore sinus rhythm, or rate-control (RateC), to lower heart rate. Current guidelines have not a preferred option for older people. OBJECTIVE This study aims at evaluating if RhythmC is more effective than RateC to hinder frailty progression and disability. METHODS The CAFFE is a prospective, multicenter, observational study enrolling 3 groups of patients: 1) >75 years, RhythmC (N=40); 2) 65-74 years, RhythmC (N=40); 3) >65 years, RateC (N=40). The 4th group (N=40) will consist of >65 years subjects without overt chronic conditions. At baseline, all subjects will undergo a geriatric evaluation (including Comprehensive Geriatric Assessment – CGA), and an analysis of inflammation and metabolomics. At home, a device will evaluate rhythm, the daily activity profile and sleep. After one month, the CGA will be repeated. The CAFFE study is granted as a Research Project of National Interest by the Italian Ministry of University and Research. RESULTS The study will compare the changes of frailty and disability by group. Secondary outcomes are to evaluate the effects of AF therapy and age on depressive symptoms, quality of life, physical and neuro-cognitive performance; to correlate inflammation or metabolomics with patients’ characteristics or CGA changes. CONCLUSIONS The CAFFE study will evaluate the AF therapy impact in older patients. If frailty and disability were controlled with RhythmC, specifically addressed clinical trials should more definitely answer these knowledge gaps. CLINICALTRIAL The CAFFE Study is not a trial