Structured care approach for older people with atrial fibrillation and other conditions
Tests a structured care program in older people with atrial fibrillation and several health conditions.
Plain-language title generated from the registry record
Registry title: Integrated Approach in Frail Older People with Atrial Fibrillation
Key facts
- Where
- Bucharest, RomaniaSee the 8 sites
Where in Romania
- Spitalul Clinic Colentina-CardiologyBucharest, RomaniaTaking people
- Spitalul Clinic Colentina-Internal MedicineBucharest, RomaniaTaking people
- Spitalul Clinic Coltea-Internal Medicine and CardiologyBucharest, RomaniaTaking people
- Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-CardiologyBucharest, RomaniaTaking people
- Spitalul Clinic de Urgenta Bucuresti-CardiologyBucharest, RomaniaTaking people
- Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and CardiologyBucharest, RomaniaTaking people
- Spitalul Universitar de Urgenta Elias-CardiologyBucharest, RomaniaTaking people
- Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function LaboratoryBucharest, RomaniaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Heart Care Foundation
- Trial code
- NCT06775028
- Record updated
- 14 January 2025
- Original description
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.Read full original descriptionShow less
AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
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 .
Inclusion: 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: Mechanical prosthetic heart valve or moderate/severe mitral stenosis; Serious diseases with a life expectancy inferior to 12 months; Patient unwilling to be enrolled and sign written informed consent; Patient unable to understand the study and attend the follow-up; Patients included in other interventional studies; Only for sites randomized to the iABC group:; Patient without a device suitable for iABC use.