Sign in

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
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

Full criteria on ClinicalTrials.gov

Sites (50)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
MHAT Haskovo AD-Cardiology
Coordinator of this site? Confirm its status
HaskovoBulgariaRecruiting
SHATS Sveti Georgi - Pernik-Cardiology
Coordinator of this site? Confirm its status
PernikBulgariaRecruiting
MBAL Sv. Ivan Rilski-Cardiology
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
UMHAT Pulmed Plovdiv-Cardiology
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
UMBAL Sveti Georgi EAD-Clinic of Cardiology
Coordinator of this site? Confirm its status
PlovdivBulgariaRecruiting
National Heart Hospital-ICCU
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
Coordinator of this site? Confirm its status
SofiaBulgariaRecruiting
Herlev Hospital-Department of Cardiology
Coordinator of this site? Confirm its status
HerlevDenmarkRecruiting
North Denmark Regional Hospital-Department of Cardiology
Coordinator of this site? Confirm its status
HjørringDenmarkRecruiting
Horsens Regional Hospital-Department of Medicine
Coordinator of this site? Confirm its status
HorsensDenmarkRecruiting
Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways
Coordinator of this site? Confirm its status
SilkeborgDenmarkRecruiting
Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY
Coordinator of this site? Confirm its status
AlicanteSpainRecruiting
Hospital General Universitario Santa Lucía-CARDIOLOGY
Coordinator of this site? Confirm its status
CartagenaSpainRecruiting
Hospital Valle del Guadalhorce-CARDIOLOGY
Coordinator of this site? Confirm its status
CártamaSpainRecruiting
Hospital General Universitario de Elche-CARDIOLOGY
Coordinator of this site? Confirm its status
ElcheSpainRecruiting
Hospital Universitario Virgen de la Victoria-CARDIOLOGY
Coordinator of this site? Confirm its status
MálagaSpainRecruiting
Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA
Coordinator of this site? Confirm its status
MurciaSpainRecruiting
Hospital General Universitario Reina Sofía-CARDIOLOGY
Coordinator of this site? Confirm its status
MurciaSpainRecruiting
Hospital Universitario San Juan de Alicante-CARDIOLOGY
Coordinator of this site? Confirm its status
Sant Joan d'AlacantSpainRecruiting
Hospital Universitario de Tarragona Joan XXIII-Cardiology
Coordinator of this site? Confirm its status
TarragonaSpainRecruiting
Pius Hospital de Valls-Cardiology
Coordinator of this site? Confirm its status
VallsSpainRecruiting
Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria
Coordinator of this site? Confirm its status
CasertaItalyRecruiting
Ospedale Santa Maria Nuova-Cardiologia - Firenze 1
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Als Genovese Palazzo Della Salute-Cardiologia Quarto
Coordinator of this site? Confirm its status
GenovaItalyRecruiting
Ospedale Della Misericordia-U.O. Di Cardiologia
Coordinator of this site? Confirm its status
GrossetoItalyRecruiting
Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia
Coordinator of this site? Confirm its status
GubbioItalyRecruiting
Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia
Coordinator of this site? Confirm its status
MonzaItalyRecruiting
Aou Federico Ii-Medicina Metabolico-Riabilitativa
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic
Coordinator of this site? Confirm its status
PiacenzaItalyRecruiting
Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica
Coordinator of this site? Confirm its status
RomaItalyRecruiting
Azienda Ospedaliera Santa Maria-Medicina Interna
Coordinator of this site? Confirm its status
TerniItalyRecruiting
Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia
Coordinator of this site? Confirm its status
UdineItalyRecruiting
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Coltea-Internal Medicine and Cardiology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Colentina-Internal Medicine
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Colentina-Cardiology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic de Urgenta Bucuresti-Cardiology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Universitar de Urgenta Elias-Cardiology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology
Coordinator of this site? Confirm its status
BucharestRomaniaRecruiting
Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
University Clinical Centre of Serbia-Department for invasive electrophysiology
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
University Clinical Centre of Serbia-Emergency centre
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
KBC Zemun-Cardiology Department
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
KBC Bezanijska Kosa-Cardiology Department
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
University Clinical Centre of Serbia-Department for cardiac arrhythmias
Coordinator of this site? Confirm its status
BelgradeSerbiaRecruiting
University Clinical Centre of Kragujevac-Cardiology Department
Coordinator of this site? Confirm its status
KragujevacSerbiaRecruiting
University Clinical Centre of Nis-Cardiology Department
Coordinator of this site? Confirm its status
NišSerbiaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.