AFFIRMO Trial: Rationale, Design and Baseline Characteristics
- 29 January 2026
The AFFIRMO consortium has published a new paper in the American Heart Journal detailing the design, rationale, and baseline characteristics of the AFFIRMO trial. The paper is titled "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".
Atrial fibrillation is the most common heart rhythm disorder in older adults and often co-exists with frailty and multiple long-term illnesses. Recognising the complex needs of this vulnerable population, the AFFIRMO trial is evaluating whether a mobile-health supported, comprehensive care pathway can make a meaningful difference. The intervention combines the evidence-based Atrial Fibrillation Better Care (ABC) framework with comprehensive geriatric assessment, aiming to reduce unplanned hospitalizations and other adverse outcomes over 12 months.
This multicentre, open-label, cluster-randomized trial has enrolled 1,260 patients aged 65 and older across six European countries. The cohort reflects the real-world complexity of treating atrial fibrillation in older adults, with broad representation of multimorbidity and frailty among participants. At baseline, common conditions included hypertension and diabetes, and nearly half of participants were classified as pre-frail or frail.
By integrating the ABC pathway with comprehensive geriatric assessment, the AFFIRMO trial will provide crucial evidence on whether this patient-centred approach can effectively reduce unplanned hospitalizations and improve clinical outcomes in older, multimorbid patients living with atrial fibrillation.
Authors:
Marco Proietti MD PhD, Gregory Y.H. Lip MD, John Ainsworth MSc PhD, Gheorghe-Andrei Dan MD PhD, Lars Frost MD MSc, Guendalina Graffigna PhD, Donata Lucci MS, Francisco Marin MD PhD, Tatjana S. Potpara MD PhD, Alam Sanaullah, Mariya Tokmakova MD PhD, Søren Paaske Johnsen MD PhD, Aldo Pietro Maggioni MD, AFFIRMO Study Investigators and Consortium
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