Integrated Approach in Frail Older People with Atrial Fibrillation

NCT06775028 · tracked via the Priya Life Science Italy tracker

Sponsor

Heart Care Foundation

Phase

Not applicable

Started

2024-04-11

Last updated

2025-01-14

Condition(s) studied

Atrial Fibrillation (AF)HypertensionCoronary Arterial Disease (CAD)Heart FailureCOPDPeripheral Arterial DiseaseCKDDiabetes MellitusStrokeTIA (Transient Ischemic Attack)

Investigational drug(s) / intervention(s)

iABC platform use

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.

Study 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

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Impact of iABC on all cause unplanned hospitalization — 12 months
All-cause unplanned hospitalization

Trial sites (50)

Facility	City	Region	Status
MHAT Haskovo AD-Cardiology	Haskovo	Bulgaria	Recruiting
SHATS Sveti Georgi - Pernik-Cardiology	Pernik	Bulgaria	Recruiting
MBAL Sv. Ivan Rilski-Cardiology	Plovdiv	Bulgaria	Recruiting
UMBAL Sveti Georgi EAD-Clinic of Cardiology	Plovdiv	Bulgaria	Recruiting
UMHAT Pulmed Plovdiv-Cardiology	Plovdiv	Bulgaria	Recruiting
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology	Sofia	Bulgaria	Recruiting
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY	Sofia	Bulgaria	Recruiting
National Heart Hospital-ICCU	Sofia	Bulgaria	Recruiting
Herlev Hospital-Department of Cardiology	Herlev	Denmark	Recruiting
North Denmark Regional Hospital-Department of Cardiology	Hjørring	Denmark	Recruiting
Horsens Regional Hospital-Department of Medicine	Horsens	Denmark	Recruiting
Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways	Silkeborg	Denmark	Recruiting
Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria	Caserta	CE	Recruiting
Ospedale Santa Maria Nuova-Cardiologia - Firenze 1	Florence	FI	Recruiting
Als Genovese Palazzo Della Salute-Cardiologia Quarto	Genova	GE	Recruiting
Ospedale Della Misericordia-U.O. Di Cardiologia	Grosseto	GR	Recruiting
Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia	Monza	MB	Recruiting
Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute	Milan	MI	Recruiting
Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic	Piacenza	PC	Recruiting
Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia	Gubbio	PG	Recruiting
Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica	Roma	RM	Recruiting
Azienda Ospedaliera Santa Maria-Medicina Interna	Terni	TR	Recruiting
Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia	Udine	UD	Recruiting
Aou Federico Ii-Medicina Metabolico-Riabilitativa	Naples	Italy	Recruiting
Spitalul Clinic Colentina-Cardiology	Bucharest	Romania	Recruiting
Spitalul Clinic Colentina-Internal Medicine	Bucharest	Romania	Recruiting
Spitalul Clinic Coltea-Internal Medicine and Cardiology	Bucharest	Romania	Recruiting
Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology	Bucharest	Romania	Recruiting
Spitalul Clinic de Urgenta Bucuresti-Cardiology	Bucharest	Romania	Recruiting
Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology	Bucharest	Romania	Recruiting
Spitalul Universitar de Urgenta Elias-Cardiology	Bucharest	Romania	Recruiting
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory	Bucharest	Romania	Recruiting
Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department	Belgrade	Serbia	Recruiting
KBC Bezanijska Kosa-Cardiology Department	Belgrade	Serbia	Recruiting
KBC Zemun-Cardiology Department	Belgrade	Serbia	Recruiting
University Clinical Centre of Serbia-Department for cardiac arrhythmias	Belgrade	Serbia	Recruiting
University Clinical Centre of Serbia-Department for invasive electrophysiology	Belgrade	Serbia	Recruiting
University Clinical Centre of Serbia-Emergency centre	Belgrade	Serbia	Recruiting
University Clinical Centre of Kragujevac-Cardiology Department	Kragujevac	Serbia	Recruiting
University Clinical Centre of Nis-Cardiology Department	Niš	Serbia	Recruiting

+ 10 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06775028 on ClinicalTrials.gov ↗ ← All trials in Italy