Arrhythmias & electrophysiologyTrial design
Integrated care management for older multimorbid patients with atrial fibrillation: Rationale, design and baseline characteristics for the atrial fibrillation integrated approach in frail, multimorbid and polymedicated older people (AFFIRMO) trial
- European multicenter, open-label, cluster-randomized study
Study context
- Population
- Patients with atrial fibrillation (AF) ≥65 years with ≥1 concomitant chronic condition(s), across 6 European countries (Bulgaria, Denmark, Italy, Romania, Serbia, and Spain)patients with AF enrolled
- Participants
- 1,260 patients
- Planned comparison
- mobile-health integrated care approach based on the ABC pathway combined with a multidimensional Comprehensive Geriatric Assessment (CGA)
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics
- mean age (SD) years
- 74 [SD 6]
- female
- 44.4%
- median (IQR) CHA2DS2-VASc score
- 4 (3-5)
- median (IQR) HAS-BLED score
- 1 (1-2)
- Hypertension
- 992 (78.7%)
- diabetes mellitus
- 369 (29.3%)
- prefrail
- 507 (40.5%)
- frail
- 171 (13.7%)
- Oral anticoagulants (oral anticoagulants (OACs)) prescribed
- 1,225 (97.2%)
- receiving NOACs
- 1,149 (91.2%)
Study conduct
- Follow-up is ongoing and planned to be completed in January 2026.
Original publication
Integrated care management for older multimorbid patients with atrial fibrillation: Rationale, design and baseline characteristics for the atrial fibrillation integrated approach in frail, multimorbid and polymedicated older people (AFFIRMO) trial. Am Heart J. Published 22 January 2026. doi:10.1016/j.ahj.2026.107356
Summarised from the published abstract; every number is checked against it