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| Name | Class |
|---|---|
| Aalborg University | OTHER |
| University of Belgrade | OTHER |
| Universidad de Murcia | OTHER |
| Carol Davila University of Medicine and Pharmacy |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quality-improvement intervention (iABC) | Experimental | 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. |
|
| Usual care | No Intervention | Patients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iABC platform use | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of iABC on all cause unplanned hospitalization | All-cause unplanned hospitalization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death | A 'composite endpoint' of nonfatal ischemic stroke, transient ischemic attack, and cardiovascular death | 12 months |
| Impact of iABC on secondary outcome measures |
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Inclusion Criteria:
Exclusion Criteria:
Only for sites randomized to the iABC group:
- Patient without a device suitable for iABC use.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aldo P Maggioni, MD | Contact | +390555101211 | affirmo@heartcarefoundation.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MHAT Haskovo AD-Cardiology | Recruiting | Haskovo | Bulgaria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41580107 | Derived | 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 May;295:107356. doi: 10.1016/j.ahj.2026.107356. Epub 2026 Jan 22. |
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| OTHER |
| Plovdiv Medical University | OTHER |
| University of Liverpool | OTHER |
Cluster randomized trial
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all-cause mortality |
| 12 months |
| Impact of iABC on secondary outcome measures | all-cause mortality and all-cause (planned and unplanned) hospitalizations | 12 months |
| Impact of iABC on secondary outcome measures | new diagnosis of HF or worsening HF requiring hospitalizations | 12 months |
| Impact of iABC on secondary outcome measures | quality of life assessed with EQ-5D-5L questionnaire | 12 months |
| Impact of iABC on secondary outcome measures | major bleeds defined according to the ISTH definitions | 12 months |
| Impact of iABC on secondary outcome measures | intracranial bleeds | 12 months |
| Impact of iABC on secondary outcome measures | occurrence of renal dysfunction or worsening renal function | 12 months |
| Level of adherence to iABC pathway | Level of adherence to iABC pathway will be evaluated by:
| 12 months |
| Impact of iABC on self reported physical activity | Impact of iABC on self reported physical activity | 12 months |
| Level of empowerment and engagement of patient assessed with PHE-S questionnaire | Level of empowerment and engagement of patient assessed with PHE-S questionnaire | 12 months |
| Therapy adherence | Will be evaluated by persistence medical treatment at 12 month follow-up as reported in the e-CRF | 12 months |
| SHATS Sveti Georgi - Pernik-Cardiology | Recruiting | Pernik | Bulgaria |
|
| MBAL Sv. Ivan Rilski-Cardiology | Recruiting | Plovdiv | Bulgaria |
|
| UMBAL Sveti Georgi EAD-Clinic of Cardiology | Recruiting | Plovdiv | Bulgaria |
|
| UMHAT Pulmed Plovdiv-Cardiology | Recruiting | Plovdiv | Bulgaria |
|
| Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology | Recruiting | Sofia | Bulgaria |
|
| Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY | Recruiting | Sofia | Bulgaria |
|
| National Heart Hospital-ICCU | Recruiting | Sofia | Bulgaria |
|
| Herlev Hospital-Department of Cardiology | Recruiting | Herlev | Denmark |
|
| North Denmark Regional Hospital-Department of Cardiology | Recruiting | Hjørring | Denmark |
|
| Horsens Regional Hospital-Department of Medicine | Recruiting | Horsens | Denmark |
|
| Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways | Recruiting | Silkeborg | Denmark |
|
| Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria | Recruiting | Caserta | CE | 81100 | Italy |
|
| Ospedale Santa Maria Nuova-Cardiologia - Firenze 1 | Recruiting | Florence | FI | 50122 | Italy |
|
| Als Genovese Palazzo Della Salute-Cardiologia Quarto | Recruiting | Genova | GE | 16100 | Italy |
|
| Ospedale Della Misericordia-U.O. Di Cardiologia | Recruiting | Grosseto | GR | 58100 | Italy |
|
| Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia | Recruiting | Monza | MB | 20900 | Italy |
|
| Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute | Recruiting | Milan | MI | 20138 | Italy |
|
| Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic | Recruiting | Piacenza | PC | 29100 | Italy |
|
| Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia | Recruiting | Gubbio | PG | 06024 | Italy |
|
| Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica | Recruiting | Roma | RM | 00161 | Italy |
|
| Azienda Ospedaliera Santa Maria-Medicina Interna | Recruiting | Terni | TR | 05100 | Italy |
|
| Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia | Recruiting | Udine | UD | 33100 | Italy |
|
| Aou Federico Ii-Medicina Metabolico-Riabilitativa | Recruiting | Naples | 80131 | Italy |
|
| Spitalul Clinic Colentina-Cardiology | Recruiting | Bucharest | Romania |
|
| Spitalul Clinic Colentina-Internal Medicine | Recruiting | Bucharest | Romania |
|
| Spitalul Clinic Coltea-Internal Medicine and Cardiology | Recruiting | Bucharest | Romania |
|
| Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology | Recruiting | Bucharest | Romania |
|
| Spitalul Clinic de Urgenta Bucuresti-Cardiology | Recruiting | Bucharest | Romania |
|
| Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology | Recruiting | Bucharest | Romania |
|
| Spitalul Universitar de Urgenta Elias-Cardiology | Recruiting | Bucharest | Romania |
|
| Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory | Recruiting | Bucharest | Romania |
|
| Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department | Recruiting | Belgrade | Serbia |
|
| KBC Bezanijska Kosa-Cardiology Department | Recruiting | Belgrade | Serbia |
|
| KBC Zemun-Cardiology Department | Recruiting | Belgrade | Serbia |
|
| University Clinical Centre of Serbia-Department for cardiac arrhythmias | Recruiting | Belgrade | Serbia |
|
| University Clinical Centre of Serbia-Department for invasive electrophysiology | Recruiting | Belgrade | Serbia |
|
| University Clinical Centre of Serbia-Emergency centre | Recruiting | Belgrade | Serbia |
|
| University Clinical Centre of Kragujevac-Cardiology Department | Recruiting | Kragujevac | Serbia |
|
| University Clinical Centre of Nis-Cardiology Department | Recruiting | Niš | Serbia |
|
| Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY | Recruiting | Alicante | Spain |
|
| Hospital General Universitario Santa Lucía-CARDIOLOGY | Recruiting | Cartagena | Spain |
|
| Hospital Valle del Guadalhorce-CARDIOLOGY | Recruiting | Cártama | Spain |
|
| Hospital General Universitario de Elche-CARDIOLOGY | Recruiting | Elche | Spain |
|
| Hospital Universitario Virgen de la Victoria-CARDIOLOGY | Recruiting | Málaga | Spain |
|
| Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA | Recruiting | Murcia | Spain |
|
| Hospital General Universitario Reina Sofía-CARDIOLOGY | Recruiting | Murcia | Spain |
|
| Hospital Universitario San Juan de Alicante-CARDIOLOGY | Recruiting | Sant Joan d'Alacant | Spain |
|
| Hospital Universitario de Tarragona Joan XXIII-Cardiology | Recruiting | Tarragona | Spain |
|
| Pius Hospital de Valls-Cardiology | Recruiting | Valls | Spain |
|
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006973 | Hypertension |
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D058729 | Peripheral Arterial Disease |
| D003920 | Diabetes Mellitus |
| D020521 | Stroke |
| D002546 | Ischemic Attack, Transient |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D016491 | Peripheral Vascular Diseases |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002545 | Brain Ischemia |
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