RecruitingNot ApplicableNCT06775028

Integrated Approach in Frail Older People with Atrial Fibrillation

AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People

Sponsor

Heart Care Foundation

Enrollment

1,250 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Diabetes Mellitus Hypertension Peripheral Arterial Disease Stroke COPD Atrial Fibrillation (AF)CKD Coronary Arterial Disease (CAD)TIA (Transient Ischemic Attack)

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

Min Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an integrated care approach for older adults with atrial fibrillation (an irregular heartbeat) who also have multiple other health conditions. Atrial fibrillation can increase the risk of stroke and heart failure, and managing it becomes more complex when patients also have conditions like diabetes, kidney disease, or heart failure. **You may be eligible if...** - You are 65 years or older - You have been diagnosed with atrial fibrillation (any type) - You have at least one other long-term condition such as high blood pressure (on 2+ medications), coronary artery disease, diabetes, heart failure, stroke/TIA, COPD, or kidney disease **You may NOT be eligible if...** - You have a mechanical heart valve or severe mitral valve narrowing - You are unwilling or unable to participate in follow-up visits - You have a serious illness with a short life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERiABC platform use

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)

MHAT Haskovo AD-Cardiology

Haskovo, Bulgaria

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

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

Herlev Hospital-Department of Cardiology

Herlev, Denmark

North Denmark Regional Hospital-Department of Cardiology

Hjørring, Denmark

Horsens Regional Hospital-Department of Medicine

Horsens, Denmark

Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways

Silkeborg, Denmark

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

Aou Federico Ii-Medicina Metabolico-Riabilitativa

Naples, Italy

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

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

University Clinical Centre of Kragujevac-Cardiology Department

Kragujevac, Serbia

University Clinical Centre of Nis-Cardiology Department

Niš, Serbia

Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY

Alicante, Spain

Hospital General Universitario Santa Lucía-CARDIOLOGY

Cartagena, Spain

Hospital Valle del Guadalhorce-CARDIOLOGY

Cártama, Spain

Hospital General Universitario de Elche-CARDIOLOGY

Elche, Spain

Hospital Universitario Virgen de la Victoria-CARDIOLOGY

Málaga, Spain

Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA

Murcia, Spain

Hospital General Universitario Reina Sofía-CARDIOLOGY

Murcia, Spain

Hospital Universitario San Juan de Alicante-CARDIOLOGY

Sant Joan d'Alacant, Spain

Hospital Universitario de Tarragona Joan XXIII-Cardiology

Tarragona, Spain

Pius Hospital de Valls-Cardiology

Valls, Spain

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