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
- Caserta, Florence, Genova, Grosseto, Gubbio, Milan, Monza, Naples, Piacenza, Roma, Terni, and Udine, ItalySee the 12 sites
Where in Italy
- Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica UniversitariaCaserta, ItalyTaking people
- Ospedale Santa Maria Nuova-Cardiologia - Firenze 1Florence, ItalyTaking people
- Als Genovese Palazzo Della Salute-Cardiologia QuartoGenova, ItalyTaking people
- Ospedale Della Misericordia-U.O. Di CardiologiaGrosseto, ItalyTaking people
- Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E CardiologiaGubbio, ItalyTaking people
- Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure SubacuteMilan, ItalyTaking people
- Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. CardiologiaMonza, ItalyTaking people
- Aou Federico Ii-Medicina Metabolico-RiabilitativaNaples, ItalyTaking people
- Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E UticPiacenza, ItalyTaking people
- Policlinico Umberto Primo-Medicina Interna E Immunologia ClinicaRoma, ItalyTaking people
- Azienda Ospedaliera Santa Maria-Medicina InternaTerni, ItalyTaking people
- Pou "Santa Maria Della Misericordia"-S.O.C. CardiologiaUdine, ItalyTaking 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.