Integrated Approach in Frail Older People with Atrial Fibrillation
AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
Heart Care Foundation
1,250 participants
Apr 11, 2024
INTERVENTIONAL
Conditions
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 .
Eligibility
Inclusion Criteria3
- Outpatients of both sexes with age ≥65 years;
- First diagnosed, paroxysmal, persistent, long-standing persistent or permanent AF, confirmed as per guideline-recommended diagnostic criteria for AF, e.g. with electrocardiogram (ECG) or Holter monitoring;
- ≥1 additional long-term comorbidity, thus fulfilling the definition of multimorbidity: hypertension (treated with at least 2 antihypertensive drugs), coronary artery disease (CAD), peripheral artery disease, heart failure, stroke/TIA, diabetes mellitus, COPD, CKD.
Exclusion Criteria7
- Mechanical prosthetic heart valve or moderate/severe mitral stenosis;
- Patient unwilling to be enrolled and sign written informed consent;
- Patient unable to understand the study and attend the follow-up;
- Serious diseases with a life expectancy inferior to 12 months;
- Patients included in other interventional studies.
- Only for sites randomized to the iABC group:
- \- Patient without a device suitable for iABC use.
Interventions
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.
Locations(50)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06775028