NCT06775028Recruiting
Integrated Approach in Frail Older People with Atrial Fibrillation
AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People
Source: ClinicalTrials.gov · Last updated 14 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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 .
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1250 (estimated)
- First submitted
- 31 Dec 2024
- Start date
- 11 Apr 2024
- Primary completion date
- 31 Jan 2026
- Lead sponsor
- Heart Care Foundation
- Diseases
- Heart failure, Stroke, Atrial fibrillation, COPD, High blood pressure
- NCT number
- NCT06775028
What you commit to
- Study type: Interventional
- Planned participants: 1250
- From 11 Apr 2024 to the primary completion date, 31 Jan 2026
- 50 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Mechanical prosthetic heart valve or moderate/severe mitral stenosis;
- Serious diseases with a life expectancy inferior to 12 months;
Other
- Patient unwilling to be enrolled and sign written informed consent;
- Patient unable to understand the study and attend the follow-up;
- Patients included in other interventional studies.
- Only for sites randomized to the iABC group:
- \- Patient without a device suitable for iABC use.
Who the study is looking for
- 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.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (50)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MHAT Haskovo AD-Cardiology Coordinator of this site? Confirm its status | Haskovo | Bulgaria | Recruiting |
| SHATS Sveti Georgi - Pernik-Cardiology Coordinator of this site? Confirm its status | Pernik | Bulgaria | Recruiting |
| MBAL Sv. Ivan Rilski-Cardiology Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| UMHAT Pulmed Plovdiv-Cardiology Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| UMBAL Sveti Georgi EAD-Clinic of Cardiology Coordinator of this site? Confirm its status | Plovdiv | Bulgaria | Recruiting |
| National Heart Hospital-ICCU Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Herlev Hospital-Department of Cardiology Coordinator of this site? Confirm its status | Herlev | Denmark | Recruiting |
| North Denmark Regional Hospital-Department of Cardiology Coordinator of this site? Confirm its status | Hjørring | Denmark | Recruiting |
| Horsens Regional Hospital-Department of Medicine Coordinator of this site? Confirm its status | Horsens | Denmark | Recruiting |
| Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways Coordinator of this site? Confirm its status | Silkeborg | Denmark | Recruiting |
| Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY Coordinator of this site? Confirm its status | Alicante | Spain | Recruiting |
| Hospital General Universitario Santa Lucía-CARDIOLOGY Coordinator of this site? Confirm its status | Cartagena | Spain | Recruiting |
| Hospital Valle del Guadalhorce-CARDIOLOGY Coordinator of this site? Confirm its status | Cártama | Spain | Recruiting |
| Hospital General Universitario de Elche-CARDIOLOGY Coordinator of this site? Confirm its status | Elche | Spain | Recruiting |
| Hospital Universitario Virgen de la Victoria-CARDIOLOGY Coordinator of this site? Confirm its status | Málaga | Spain | Recruiting |
| Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital General Universitario Reina Sofía-CARDIOLOGY Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario San Juan de Alicante-CARDIOLOGY Coordinator of this site? Confirm its status | Sant Joan d'Alacant | Spain | Recruiting |
| Hospital Universitario de Tarragona Joan XXIII-Cardiology Coordinator of this site? Confirm its status | Tarragona | Spain | Recruiting |
| Pius Hospital de Valls-Cardiology Coordinator of this site? Confirm its status | Valls | Spain | Recruiting |
| Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria Coordinator of this site? Confirm its status | Caserta | Italy | Recruiting |
| Ospedale Santa Maria Nuova-Cardiologia - Firenze 1 Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Als Genovese Palazzo Della Salute-Cardiologia Quarto Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| Ospedale Della Misericordia-U.O. Di Cardiologia Coordinator of this site? Confirm its status | Grosseto | Italy | Recruiting |
| Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia Coordinator of this site? Confirm its status | Gubbio | Italy | Recruiting |
| Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Aou Federico Ii-Medicina Metabolico-Riabilitativa Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic Coordinator of this site? Confirm its status | Piacenza | Italy | Recruiting |
| Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Azienda Ospedaliera Santa Maria-Medicina Interna Coordinator of this site? Confirm its status | Terni | Italy | Recruiting |
| Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia Coordinator of this site? Confirm its status | Udine | Italy | Recruiting |
| Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Coltea-Internal Medicine and Cardiology Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colentina-Internal Medicine Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Colentina-Cardiology Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic de Urgenta Bucuresti-Cardiology Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Universitar de Urgenta Elias-Cardiology Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology Coordinator of this site? Confirm its status | Bucharest | Romania | Recruiting |
| Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| University Clinical Centre of Serbia-Department for invasive electrophysiology Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| University Clinical Centre of Serbia-Emergency centre Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| KBC Zemun-Cardiology Department Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| KBC Bezanijska Kosa-Cardiology Department Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| University Clinical Centre of Serbia-Department for cardiac arrhythmias Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| University Clinical Centre of Kragujevac-Cardiology Department Coordinator of this site? Confirm its status | Kragujevac | Serbia | Recruiting |
| University Clinical Centre of Nis-Cardiology Department Coordinator of this site? Confirm its status | Niš | Serbia | Recruiting |
Related publications
- Integrated care management and comprehensive geriatric assessment using a mHealth-based approach in older multimorbid patients with atrial fibrillation: the AFFIRMO cluster-randomised trial.Lancet Reg Health Eur · 2026 · PMID 42819749
- 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 · PMID 41580107
This page is information, not medical advice. Discuss any trial with your doctor.