Clinical trial NCT06775028: Integrated Approach in Frail Older People with Atrial Fibrillation
Official title: AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation (AF)
Hypertension
Coronary Arterial Disease (CAD)
Heart Failure
COPD
Peripheral Arterial Disease
CKD
Diabetes Mellitus
Stroke
TIA (Transient Ischemic Attack)
Keywords: iABC
Atrial Fibrillation
Cluster Trial
Lead sponsor: Heart Care Foundation
Sponsor class: OTHER
Collaborators: name: Aalborg University
name: Faculty of Medicine, University of Belgrade
name: Universidad de Murcia
name: Carol Davila University of Medicine and Pharmacy
name: Plovdiv Medical University
name: University of Liverpool
First posted: 2025-01-14
Enrollment: 1250
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: Impact of iABC on all cause unplanned hospitalization
timeFrame: 12 months
Secondary outcomes:
measure: Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Impact of iABC on secondary outcome measures
timeFrame: 12 months
measure: Level of adherence to iABC pathway
timeFrame: 12 months
measure: Impact of iABC on self reported physical activity
timeFrame: 12 months
measure: Level of empowerment and engagement of patient assessed with PHE-S questionnaire
timeFrame: 12 months
measure: Therapy adherence
timeFrame: 12 months
Other outcomes:
Locations:
city: Haskovo
country: Bulgaria
facility: MHAT Haskovo AD-Cardiology
city: Pernik
country: Bulgaria
facility: SHATS Sveti Georgi - Pernik-Cardiology
city: Plovdiv
country: Bulgaria
facility: MBAL Sv. Ivan Rilski-Cardiology
city: Plovdiv
country: Bulgaria
facility: UMBAL Sveti Georgi EAD-Clinic of Cardiology
city: Plovdiv
country: Bulgaria
facility: UMHAT Pulmed Plovdiv-Cardiology
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
city: Sofia
country: Bulgaria
facility: National Heart Hospital-ICCU
city: Herlev
country: Denmark
facility: Herlev Hospital-Department of Cardiology
city: Hjoerring
country: Denmark
facility: North Denmark Regional Hospital-Department of Cardiology
city: Horsens
country: Denmark
facility: Horsens Regional Hospital-Department of Medicine
city: Silkeborg
country: Denmark
facility: Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways
city: Caserta
country: Italy
facility: Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria
state: CE
city: Firenze
country: Italy
facility: Ospedale Santa Maria Nuova-Cardiologia - Firenze 1
state: FI
city: Genova
country: Italy
facility: Als Genovese Palazzo Della Salute-Cardiologia Quarto
state: GE
city: Grosseto
country: Italy
facility: Ospedale Della Misericordia-U.O. Di Cardiologia
state: GR
city: Monza
country: Italy
facility: Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia
state: MB
city: Milano
country: Italy
facility: Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute
state: MI
city: Piacenza
country: Italy
facility: Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic
state: PC
city: Gubbio
country: Italy
facility: Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia
state: PG
city: Roma
country: Italy
facility: Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
state: RM
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria-Medicina Interna
state: TR
city: Udine
country: Italy
facility: Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia
state: UD
city: Napoli
country: Italy
facility: Aou Federico Ii-Medicina Metabolico-Riabilitativa
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina-Cardiology
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina-Internal Medicine
city: Bucuresti
country: Romania
facility: Spitalul Clinic Coltea-Internal Medicine and Cardiology
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Urgenta Bucuresti-Cardiology
city: Bucuresti
country: Romania
facility: Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Elias-Cardiology
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department
city: Belgrade
country: Serbia
facility: KBC Bezanijska Kosa-Cardiology Department
city: Belgrade
country: Serbia
facility: KBC Zemun-Cardiology Department
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia-Department for cardiac arrhythmias
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia-Department for invasive electrophysiology
city: Belgrade
country: Serbia
facility: University Clinical Centre of Serbia-Emergency centre
city: Kragujevac
country: Serbia
facility: University Clinical Centre of Kragujevac-Cardiology Department
city: NIS
country: Serbia
facility: University Clinical Centre of Nis-Cardiology Department
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY
city: Cartagena
country: Spain
facility: Hospital General Universitario Santa Lucía-CARDIOLOGY
city: Cartama
country: Spain
facility: Hospital Valle del Guadalhorce-CARDIOLOGY
city: Elche
country: Spain
facility: Hospital General Universitario de Elche-CARDIOLOGY
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria-CARDIOLOGY
city: Murcia
country: Spain
facility: Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA
city: Murcia
country: Spain
facility: Hospital General Universitario Reina Sofía-CARDIOLOGY
city: Sant Joan D'alacant
country: Spain
facility: Hospital Universitario San Juan de Alicante-CARDIOLOGY
city: Tarragona
country: Spain
facility: Hospital Universitario de Tarragona Joan XXIII-Cardiology
city: Valls
country: Spain
facility: Pius Hospital de Valls-Cardiology
Study officials:
References: