Integrated Approach in Frail Older People with Atrial Fibrillation

Not Applicable

Recruiting

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

• Registration Number: NCT06775028
• Lead Sponsor: Heart Care Foundation

Brief 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 .

Detailed Description

Controlled study, testing a structured implementation of an appropriate management of elderly AF patients with multimorbidity in clinical practice (adapting the ABC pathway and integrating the means of CGA) versus usual care; it is designed to provide reliable evidence of an active holistic integrated management approach to a common, multimorbid and 'high risk' clinical condition.

AFFIRMO use a novel platform (iABC) in a cluster randomized trial design, randomizing centres to iABC versus usual care.

Centres will be selected in each participating country (Bulgaria, Denmark, Italy, Romania, Serbia and Spain) under the responsibility of National Coordinators on the basis of a demonstrated interest in managing patients with AF. The 8-10 participating clusters in each country (see study size below) will be randomized in a 1:1 ratio to receive a quality-improvement intervention (iABC, experimental group) or 'usual care' practice (control group). The randomization will occur in each Country once all clusters selected in the Country have obtained IRB approval. The allocation schedule for random assignment of care models (iABC or usual care) to sites will be computer generated at the Central Coordinating Centre. The clusters in each Country will be stratified in 2 groups: Centres with or without interventional electrophysiology laboratory for AF ablation.

Study Timeline

• Study Start: 2024-04-11
• Study First Submitted: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Impact of iABC on all cause unplanned hospitalization	12 months	All-cause unplanned hospitalization

Secondary Outcome Measures

Name	Time	Method
Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death	12 months	A 'composite endpoint' of nonfatal ischemic stroke, transient ischemic attack, and cardiovascular death
Impact of iABC on secondary outcome measures	12 months	occurrence of renal dysfunction or worsening renal function
Level of adherence to iABC pathway	12 months	Level of adherence to iABC pathway will be evaluated by: * the number of accesses to the APP.; * daily patient's adherence to oral anticoagulant therapy,; * weekly blood pressure and weight self-measurements input; * weekly AF symptoms related questionnaires completion
Impact of iABC on self reported physical activity	12 months	Impact of iABC on self reported physical activity
Level of empowerment and engagement of patient assessed with PHE-S questionnaire	12 months	Level of empowerment and engagement of patient assessed with PHE-S questionnaire
Therapy adherence	12 months	Will be evaluated by persistence medical treatment at 12 month follow-up as reported in the e-CRF

Trial Locations

Locations (50)

MHAT Haskovo AD-Cardiology; 🇧🇬 Haskovo, Bulgaria

SHATS Sveti Georgi - Pernik-Cardiology; 🇧🇬 Pernik, Bulgaria

UMBAL Sveti Georgi EAD-Clinic of Cardiology; 🇧🇬 Plovdiv, Bulgaria

Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY; 🇧🇬 Sofia, Bulgaria

National Heart Hospital-ICCU; 🇧🇬 Sofia, Bulgaria

North Denmark Regional Hospital-Department of Cardiology; 🇩🇰 Hjoerring, Denmark

Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways; 🇩🇰 Silkeborg, Denmark

MBAL Sv. Ivan Rilski-Cardiology; 🇧🇬 Plovdiv, Bulgaria

Horsens Regional Hospital-Department of Medicine; 🇩🇰 Horsens, Denmark

Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia; 🇮🇹 Monza, MB, Italy

Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic; 🇮🇹 Piacenza, PC, Italy

Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica; 🇮🇹 Roma, RM, Italy

Azienda Ospedaliera Santa Maria-Medicina Interna; 🇮🇹 Terni, TR, Italy

UMHAT Pulmed Plovdiv-Cardiology; 🇧🇬 Plovdiv, Bulgaria

Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology; 🇧🇬 Sofia, Bulgaria

Herlev Hospital-Department of Cardiology; 🇩🇰 Herlev, Denmark

Ospedale Della Misericordia-U.O. Di Cardiologia; 🇮🇹 Grosseto, GR, Italy

Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria; 🇮🇹 Caserta, CE, Italy

Als Genovese Palazzo Della Salute-Cardiologia Quarto; 🇮🇹 Genova, GE, Italy

Ospedale Santa Maria Nuova-Cardiologia - Firenze 1; 🇮🇹 Firenze, FI, Italy

Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute; 🇮🇹 Milano, MI, Italy

Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia; 🇮🇹 Gubbio, PG, Italy

Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia; 🇮🇹 Udine, UD, Italy

Aou Federico Ii-Medicina Metabolico-Riabilitativa; 🇮🇹 Napoli, Italy

Spitalul Clinic Colentina-Cardiology; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Colentina-Internal Medicine; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Coltea-Internal Medicine and Cardiology; 🇷🇴 Bucuresti, Romania

Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology; 🇷🇴 Bucuresti, Romania

Spitalul Clinic de Urgenta Bucuresti-Cardiology; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology; 🇷🇴 Bucuresti, Romania

Spitalul Universitar de Urgenta Elias-Cardiology; 🇷🇴 Bucuresti, Romania

Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory; 🇷🇴 Bucuresti, 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

Hospital General Universitario Santa Lucía-CARDIOLOGY; 🇪🇸 Cartagena, Spain

Hospital Valle del Guadalhorce-CARDIOLOGY; 🇪🇸 Cartama, Spain

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 Kragujevac-Cardiology Department; 🇷🇸 Kragujevac, Serbia

Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA; 🇪🇸 Murcia, Spain

University Clinical Centre of Serbia-Emergency centre; 🇷🇸 Belgrade, Serbia

University Clinical Centre of Nis-Cardiology Department; 🇷🇸 NIS, Serbia

Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY; 🇪🇸 Alicante, Spain

Hospital Universitario Virgen de la Victoria-CARDIOLOGY; 🇪🇸 Malaga, Spain

Hospital General Universitario de Elche-CARDIOLOGY; 🇪🇸 Elche, 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