Integrated Approach in Frail Older People with Atrial Fibrillation
NCT06775028 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1250
Last updated 2025-01-14
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 .
Conditions
- Atrial Fibrillation (AF)
- Hypertension
- Coronary Arterial Disease (CAD)
- Heart Failure
- COPD
- Peripheral Arterial Disease
- CKD
- Diabetes Mellitus
- Stroke
- TIA (Transient Ischemic Attack)
Interventions
- 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.
Sponsors & Collaborators
-
Aalborg University
collaborator OTHER -
Faculty of Medicine, University of Belgrade
collaborator UNKNOWN -
Universidad de Murcia
collaborator OTHER -
Carol Davila University of Medicine and Pharmacy
collaborator OTHER -
Plovdiv Medical University
collaborator OTHER -
University of Liverpool
collaborator OTHER -
Heart Care Foundation
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-04-11
- Primary Completion
- 2026-01-31
- Completion
- 2026-01-31
Countries
- Bulgaria
- Denmark
- Italy
- Romania
- Serbia
- Spain
Study Locations
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