AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
Status: Recruiting
Location: See all (50) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Bulgaria
MHAT Haskovo AD-Cardiology
RECRUITING
Haskovo
SHATS Sveti Georgi - Pernik-Cardiology
RECRUITING
Pernik
MBAL Sv. Ivan Rilski-Cardiology
RECRUITING
Plovdiv
UMBAL Sveti Georgi EAD-Clinic of Cardiology
RECRUITING
Plovdiv
UMHAT Pulmed Plovdiv-Cardiology
RECRUITING
Plovdiv
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
RECRUITING
Sofia
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
RECRUITING
Sofia
National Heart Hospital-ICCU
RECRUITING
Sofia
Denmark
Herlev Hospital-Department of Cardiology
RECRUITING
Herlev
North Denmark Regional Hospital-Department of Cardiology
RECRUITING
Hjørring
Horsens Regional Hospital-Department of Medicine
RECRUITING
Horsens
Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways
RECRUITING
Silkeborg
Italy
Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria
RECRUITING
Caserta
Ospedale Santa Maria Nuova-Cardiologia - Firenze 1
RECRUITING
Florence
Als Genovese Palazzo Della Salute-Cardiologia Quarto
RECRUITING
Genova
Ospedale Della Misericordia-U.O. Di Cardiologia
RECRUITING
Grosseto
Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia
RECRUITING
Gubbio
Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute
RECRUITING
Milan
Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia
RECRUITING
Monza
Aou Federico Ii-Medicina Metabolico-Riabilitativa
RECRUITING
Napoli
Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic
RECRUITING
Piacenza
Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
RECRUITING
Roma
Azienda Ospedaliera Santa Maria-Medicina Interna
RECRUITING
Terni
Pou Santa Maria Della Misericordia-S.O.C. Cardiologia
RECRUITING
Udine
Romania
Spitalul Clinic Colentina-Cardiology
RECRUITING
Bucharest
Spitalul Clinic Colentina-Internal Medicine
RECRUITING
Bucharest
Spitalul Clinic Coltea-Internal Medicine and Cardiology
RECRUITING
Bucharest
Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology
RECRUITING
Bucharest
Spitalul Clinic de Urgenta Bucuresti-Cardiology
RECRUITING
Bucharest
Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology
RECRUITING
Bucharest
Spitalul Universitar de Urgenta Elias-Cardiology
RECRUITING
Bucharest
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory
RECRUITING
Bucharest
Serbia
Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department
RECRUITING
Belgrade
KBC Bezanijska Kosa-Cardiology Department
RECRUITING
Belgrade
KBC Zemun-Cardiology Department
RECRUITING
Belgrade
University Clinical Centre of Serbia-Department for cardiac arrhythmias
RECRUITING
Belgrade
University Clinical Centre of Serbia-Department for invasive electrophysiology
RECRUITING
Belgrade
University Clinical Centre of Serbia-Emergency centre
RECRUITING
Belgrade
University Clinical Centre of Kragujevac-Cardiology Department
RECRUITING
Kragujevac
University Clinical Centre of Nis-Cardiology Department
RECRUITING
Niš
Spain
Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY
RECRUITING
Alicante
Hospital General Universitario Santa Lucía-CARDIOLOGY
RECRUITING
Cartagena
Hospital Valle del Guadalhorce-CARDIOLOGY
RECRUITING
Cártama
Hospital General Universitario de Elche-CARDIOLOGY
RECRUITING
Elche
Hospital Universitario Virgen de la Victoria-CARDIOLOGY
RECRUITING
Málaga
Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA
RECRUITING
Murcia
Hospital General Universitario Reina Sofía-CARDIOLOGY
RECRUITING
Murcia
Hospital Universitario San Juan de Alicante-CARDIOLOGY
RECRUITING
Sant Joan D'alacant
Hospital Universitario de Tarragona Joan XXIII-Cardiology
RECRUITING
Tarragona
Pius Hospital de Valls-Cardiology
RECRUITING
Valls
Contact Information
Primary
Aldo P Maggioni, MD
affirmo@heartcarefoundation.it
+390555101211
Time Frame
Start Date: 2024-04-11
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 1250
Treatments
Experimental: Quality-improvement intervention (iABC)
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.~iABC will provide guidance to obtain a more personalized care to AF patients in the experimental cluster implementing specific strategies to obtain clinical control for all the three pillars of the ABC pathway. During the entire follow-up the physician will be able to check the data imputed by the patients and, eventually, contact the patient to provide recommendations and to discuss changes to the treatments and lifestyle habits.
No_intervention: Usual care
Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance
Related Therapeutic Areas
Sponsors
Collaborators: Faculty of Medicine, University of Belgrade, Universidad de Murcia, Carol Davila University of Medicine and Pharmacy, University of Liverpool, Aalborg University, Plovdiv Medical University
Leads: Heart Care Foundation