NCT06775028

Integrated Approach in Frail Older People with Atrial Fibrillation

AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,250 (estimated)
• Sponsor: Heart Care Foundation · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The study will verify if a structured multidisciplinary approach (called iABC), aimed to improve the appropriate management of elderly AF patients with multimorbidity (the i-ABC group), would provide a clear evidence of an improvement in clinical conditions and quality of life compared to usual clinical care. The i-ABC group in AFFIRMO will follow the ABC pathway, focused on three domains: avoid stroke with anticoagulation (with optimized VKA or label-adherent DOAC use); better symptom management; and optimized management of associated cardiovascular and non cardiovascular comorbidities. The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .

Detailed description

Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition. AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care. Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.

Conditions

• Atrial Fibrillation (AF)
• Hypertension
• Coronary Arterial Disease (CAD)
• Heart Failure
• COPD
• Peripheral Arterial Disease
• CKD
• Diabetes Mellitus
• Stroke
• TIA (Transient Ischemic Attack)

Interventions

Type	Name	Description
OTHER	iABC platform use	The novel platform (iABC) that will be used in AFFIRMO will consist of an educational program, a healthy or functional diet/physical activity, guideline-adherent drug treatments, periodic (re)assessment.

Timeline

• Start date: 2024-04-11
• Primary completion: 2026-01-31
• Completion: 2026-01-31
• First posted: 2025-01-14
• Last updated: 2025-01-14

Locations

50 sites across 6 countries: Bulgaria, Denmark, Italy, Romania, Serbia, Spain