Integrated Approach in Frail Older People with Atrial Fibrillation
NCT ID: NCT06775028
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
1250 participants
INTERVENTIONAL
2024-04-11
2026-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The study will be conducted in Bulgaria, Denmark, Italy, Romania, Serbia and Spain .
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Multidisciplinary Team Approach to Prescribe Antithrombotic Therapy in Older People With Atrial Fibrillation
NCT04932603
Atrial Fibrillation Management in Congestive Heart Failure With Ablation
NCT00652522
Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
NCT06200311
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)
NCT00000556
Atrial Fibrillation in Relationship to Plasma Biomarkers
NCT04710745
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Quality-improvement intervention (iABC)
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.
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.
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.
Usual care
Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aalborg University
OTHER
Faculty of Medicine, University of Belgrade
UNKNOWN
Universidad de Murcia
OTHER
Carol Davila University of Medicine and Pharmacy
OTHER
Plovdiv Medical University
OTHER
University of Liverpool
OTHER
Heart Care Foundation
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
Roma, RM, Italy
Azienda Ospedaliera Santa Maria-Medicina Interna
Terni, TR, 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
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
ANTONY GOGOV, MD
Role: primary
KOSTADIN KICHUKOV, MD
Role: primary
KRASTYU PENCHEV, MD
Role: primary
MARIYA TOKMAKOVA, MD
Role: primary
VLADIMIR IVANOV, MD
Role: primary
VASSIL TRAYKOV, MD
Role: primary
ISKREN GARVANSKI, MD
Role: primary
ELENA KOSTOVA-DIMITROVA, MD
Role: primary
MORTEN K LAMBERTS, MD
Role: primary
ALBERT MARNI JOENSEN, MD
Role: primary
KAREN KAAE DODT, MD
Role: primary
LARS FROST, MD
Role: primary
Paolo Calabro', MD
Role: primary
Alessandro Paoletti Perini
Role: primary
Maria Luisa Biorci, MD
Role: primary
Luigi Addonisio, MD
Role: primary
Elena Pazzi, MD
Role: primary
Marco Proietti, MD
Role: primary
Deborah Cosmi, MD
Role: primary
Stefania Basili, MD
Role: primary
Giacomo Pucci, MD
Role: primary
Marzia De Biasio, MD
Role: primary
Alberto Maria Marra, MD
Role: primary
ANCA RODICA DAN, MD
Role: primary
CRISTIAN RASVAN BAICUS, MD
Role: primary
ILINCA MIHAELA SAVULESCU-FIEDLER, MD
Role: primary
CRINA SINESCU, MD
Role: primary
ALEXANDRU SCAFA-UDRISTE, MD
Role: primary
ANA MARIA BALAHURA, MD
Role: primary
SERBAN BALANESCU, MD
Role: primary
SILVIU STANCIU, MD
Role: primary
DEJAN KOJIC, MD
Role: primary
MARIJA ZDRAVKOVIC, MD
Role: primary
RADOSAV VIDAKOVIC, MD
Role: primary
TATJANA POTPARA, MD
Role: primary
NEBOJSA MUJOVIC, MD
Role: primary
TANJA JOZIC, MD
Role: primary
STEFAN SIMOVIC, MD
Role: primary
TOMISLAV KOSTIC, MD
Role: primary
AMAYA GARCÍA-FERNÁNDEZ, MD
Role: primary
IGNACIO GIL-ORTEGA, MD
Role: primary
JORGE RODRÍGUEZ CAPITÁN, MD
Role: primary
ANTONIO GARCÍA-HONRUBIA, MD
Role: primary
ALEJANDRO ISIDORO PÉREZ CABEZA, MD
Role: primary
FRANCISCO MARIN, MD
Role: primary
TOMÁS VICENTE VERA, MD
Role: primary
JOSE MORENO ARRIBAS, MD
Role: primary
JOSÉ LUÍS FERREIRO-GUTIÉRREZ, MD
Role: primary
LEYDIMAR ADEL ANMAD SHIHADEH MUSA, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
K23
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.