Integrated Approach in Frail Older People with Atrial Fibrillation
Recruiting · NCT06775028 · Interventional (participants receive a specific treatment) · Lead sponsor: Heart Care Foundation
View the official record on ClinicalTrials.gov →Interventions studied
iABC platform use
What this trial is about
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 .
Who can take part
Age range
65 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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.
- nly for sites randomized to the iABC group:
- \- Patient without a device suitable for iABC use.
Where it is running
50 locations listed.
- Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY - Alicante, Spain
- Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department - Belgrade, Serbia
- KBC Bezanijska Kosa-Cardiology Department - Belgrade, Serbia
- KBC Zemun-Cardiology Department - Belgrade, Serbia
- University Clinical Centre of Serbia-Department for cardiac arrhythmias - Belgrade, Serbia
- University Clinical Centre of Serbia-Department for invasive electrophysiology - Belgrade, Serbia
- University Clinical Centre of Serbia-Emergency centre - Belgrade, Serbia
- Spitalul Clinic Colentina-Cardiology - Bucharest, Romania
- Spitalul Clinic Colentina-Internal Medicine - Bucharest, Romania
- Spitalul Clinic Coltea-Internal Medicine and Cardiology - Bucharest, Romania
- Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology - Bucharest, Romania
- Spitalul Clinic de Urgenta Bucuresti-Cardiology - Bucharest, Romania
- Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology - Bucharest, Romania
- Spitalul Universitar de Urgenta Elias-Cardiology - Bucharest, Romania
- Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory - Bucharest, Romania
- Hospital General Universitario Santa Lucía-CARDIOLOGY - Cartagena, Spain
- Hospital Valle del Guadalhorce-CARDIOLOGY - Cártama, Spain
- Hospital General Universitario de Elche-CARDIOLOGY - Elche, Spain
- MHAT Haskovo AD-Cardiology - Haskovo, Bulgaria
- Herlev Hospital-Department of Cardiology - Herlev, Denmark
- North Denmark Regional Hospital-Department of Cardiology - Hjørring, Denmark
- Horsens Regional Hospital-Department of Medicine - Horsens, Denmark
- University Clinical Centre of Kragujevac-Cardiology Department - Kragujevac, Serbia
- Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA - Murcia, Spain
- Hospital General Universitario Reina Sofía-CARDIOLOGY - Murcia, Spain
- Hospital Universitario Virgen de la Victoria-CARDIOLOGY - Málaga, Spain
- Aou Federico Ii-Medicina Metabolico-Riabilitativa - Naples, Italy
- University Clinical Centre of Nis-Cardiology Department - Niš, Serbia
- SHATS Sveti Georgi - Pernik-Cardiology - Pernik, Bulgaria
- MBAL Sv. Ivan Rilski-Cardiology - Plovdiv, Bulgaria
- UMBAL Sveti Georgi EAD-Clinic of Cardiology - Plovdiv, Bulgaria
- UMHAT Pulmed Plovdiv-Cardiology - Plovdiv, Bulgaria
- Hospital Universitario San Juan de Alicante-CARDIOLOGY - Sant Joan d'Alacant, Spain
- Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways - Silkeborg, Denmark
- Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology - Sofia, Bulgaria
- Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY - Sofia, Bulgaria
- National Heart Hospital-ICCU - Sofia, Bulgaria
- Hospital Universitario de Tarragona Joan XXIII-Cardiology - Tarragona, Spain
- Pius Hospital de Valls-Cardiology - Valls, Spain
- Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria - Caserta, CE, Italy
- Ospedale Santa Maria Nuova-Cardiologia - Firenze 1 - Florence, FI, Italy
- Als Genovese Palazzo Della Salute-Cardiologia Quarto - Genova, GE, Italy
- Ospedale Della Misericordia-U.O. Di Cardiologia - Grosseto, GR, Italy
- Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia - Monza, MB, Italy
- Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute - Milan, MI, Italy
- Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic - Piacenza, PC, Italy
- Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia - Gubbio, PG, Italy
- Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica - Roma, RM, Italy
- Azienda Ospedaliera Santa Maria-Medicina Interna - Terni, TR, Italy
- Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia - Udine, UD, Italy