Integrated Approach in Frail Older People with Atrial Fibrillation
AFFIRMO
AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
1 other identifier
interventional
1,250
6 countries
50
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2024
Typical duration for not_applicable
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 11, 2024
CompletedFirst Submitted
Initial submission to the registry
December 31, 2024
CompletedFirst Posted
Study publicly available on registry
January 14, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2026
CompletedJanuary 14, 2025
January 1, 2025
1.8 years
December 31, 2024
January 9, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of iABC on all cause unplanned hospitalization
All-cause unplanned hospitalization
12 months
Secondary Outcomes (12)
Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death
12 months
Impact of iABC on secondary outcome measures
12 months
Impact of iABC on secondary outcome measures
12 months
Impact of iABC on secondary outcome measures
12 months
Impact of iABC on secondary outcome measures
12 months
- +7 more secondary outcomes
Study Arms (2)
Quality-improvement intervention (iABC)
EXPERIMENTALThe 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. iABC will provide guidance to obtain a more personalized care to AF patients in the experimental cluster implementing specific strategies to obtain clinical control for all the three pillars of the ABC pathway. During the entire follow-up the physician will be able to check the data imputed by the patients and, eventually, contact the patient to provide recommendations and to discuss changes to the treatments and lifestyle habits.
Usual care
NO INTERVENTIONPatients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heart Care Foundationlead
- Aalborg Universitycollaborator
- University of Belgradecollaborator
- Universidad de Murciacollaborator
- Carol Davila University of Medicine and Pharmacycollaborator
- Plovdiv Medical Universitycollaborator
- University of Liverpoolcollaborator
Study Sites (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, 81100, Italy
Ospedale Santa Maria Nuova-Cardiologia - Firenze 1
Florence, FI, 50122, Italy
Als Genovese Palazzo Della Salute-Cardiologia Quarto
Genova, GE, 16100, Italy
Ospedale Della Misericordia-U.O. Di Cardiologia
Grosseto, GR, 58100, Italy
Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia
Monza, MB, 20900, Italy
Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute
Milan, MI, 20138, Italy
Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic
Piacenza, PC, 29100, Italy
Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia
Gubbio, PG, 06024, Italy
Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
Roma, RM, 00161, Italy
Azienda Ospedaliera Santa Maria-Medicina Interna
Terni, TR, 05100, Italy
Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia
Udine, UD, 33100, Italy
Aou Federico Ii-Medicina Metabolico-Riabilitativa
Napoli, 80131, 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
Related Publications (1)
Proietti M, Lip GYH, Ainsworth J, Dan GA, Frost L, Graffigna G, Lucci D, Marin F, Potpara TS, Sanaullah A, Tokmakova M, Johnsen SP, Maggioni AP; AFFIRMO Study Investigators and Consortium. Integrated Care Management for Older Multimorbid Patients with Atrial Fibrillation: Rationale, Design and Baseline Characteristics for the Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People (AFFIRMO) trial. Am Heart J. 2026 Jan 22:107356. doi: 10.1016/j.ahj.2026.107356. Online ahead of print.
PMID: 41580107DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2024
First Posted
January 14, 2025
Study Start
April 11, 2024
Primary Completion
January 31, 2026
Study Completion
January 31, 2026
Last Updated
January 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share