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RECRUITINGINTERVENTIONAL

Integrated Approach in Frail Older People with Atrial Fibrillation

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - Mechanical prosthetic heart valve or moderate/severe mitral stenosis; - Patient unwilling to be enrolled and sign written willing to sign a consent form; - 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. Only for sites randomized to the iABC group: \- Patient without a device suitable for iABC use. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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. Only for sites randomized to the iABC group: \- Patient without a device suitable for iABC use.

Treatments Being Tested

OTHER

iABC 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 (20)

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