Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06775028

Integrated Approach in Frail Older People with Atrial Fibrillation

Led by Heart Care Foundation · Updated on 2025-01-14

1250

Participants Needed

50

Research Sites

94 weeks

Total Duration

On this page

Sponsors

H

Heart Care Foundation

Lead Sponsor

A

Aalborg University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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 .

CONDITIONS

Official Title

Integrated Approach in Frail Older People with Atrial Fibrillation

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Outpatients aged 65 years or older
  • Diagnosis of atrial fibrillation (paroxysmal, persistent, long-standing persistent or permanent) confirmed by ECG or Holter monitoring
  • At least one additional long-term health condition such as hypertension treated with at least 2 drugs, coronary artery disease, peripheral artery disease, heart failure, stroke or transient ischemic attack, diabetes mellitus, COPD, or chronic kidney disease
Not Eligible

You will not qualify if you...

  • Mechanical prosthetic heart valve or moderate to severe mitral stenosis
  • Patient unwilling to be enrolled or unable to provide written informed consent
  • Patient unable to understand the study or attend follow-up visits
  • Serious disease with life expectancy less than 12 months
  • Participation in other interventional studies
  • For iABC group sites, lack of a device suitable for using the iABC platform

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 50 locations

1

MHAT Haskovo AD-Cardiology

Haskovo, Bulgaria

Actively Recruiting

2

SHATS Sveti Georgi - Pernik-Cardiology

Pernik, Bulgaria

Actively Recruiting

3

MBAL Sv. Ivan Rilski-Cardiology

Plovdiv, Bulgaria

Actively Recruiting

4

UMBAL Sveti Georgi EAD-Clinic of Cardiology

Plovdiv, Bulgaria

Actively Recruiting

5

UMHAT Pulmed Plovdiv-Cardiology

Plovdiv, Bulgaria

Actively Recruiting

6

Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology

Sofia, Bulgaria

Actively Recruiting

7

Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY

Sofia, Bulgaria

Actively Recruiting

8

National Heart Hospital-ICCU

Sofia, Bulgaria

Actively Recruiting

9

Herlev Hospital-Department of Cardiology

Herlev, Denmark

Actively Recruiting

10

North Denmark Regional Hospital-Department of Cardiology

Hjørring, Denmark

Actively Recruiting

11

Horsens Regional Hospital-Department of Medicine

Horsens, Denmark

Actively Recruiting

12

Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innovative Patient Pathways

Silkeborg, Denmark

Actively Recruiting

13

Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria

Caserta, CE, Italy, 81100

Actively Recruiting

14

Ospedale Santa Maria Nuova-Cardiologia - Firenze 1

Florence, FI, Italy, 50122

Actively Recruiting

15

Als Genovese Palazzo Della Salute-Cardiologia Quarto

Genova, GE, Italy, 16100

Actively Recruiting

16

Ospedale Della Misericordia-U.O. Di Cardiologia

Grosseto, GR, Italy, 58100

Actively Recruiting

17

Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia

Monza, MB, Italy, 20900

Actively Recruiting

18

Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute

Milan, MI, Italy, 20138

Actively Recruiting

19

Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic

Piacenza, PC, Italy, 29100

Actively Recruiting

20

Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia

Gubbio, PG, Italy, 06024

Actively Recruiting

21

Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica

Roma, RM, Italy, 00161

Actively Recruiting

22

Azienda Ospedaliera Santa Maria-Medicina Interna

Terni, TR, Italy, 05100

Actively Recruiting

23

Pou "Santa Maria Della Misericordia"-S.O.C. Cardiologia

Udine, UD, Italy, 33100

Actively Recruiting

24

Aou Federico Ii-Medicina Metabolico-Riabilitativa

Naples, Italy, 80131

Actively Recruiting

25

Spitalul Clinic Colentina-Cardiology

Bucharest, Romania

Actively Recruiting

26

Spitalul Clinic Colentina-Internal Medicine

Bucharest, Romania

Actively Recruiting

27

Spitalul Clinic Coltea-Internal Medicine and Cardiology

Bucharest, Romania

Actively Recruiting

28

Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology

Bucharest, Romania

Actively Recruiting

29

Spitalul Clinic de Urgenta Bucuresti-Cardiology

Bucharest, Romania

Actively Recruiting

30

Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology

Bucharest, Romania

Actively Recruiting

31

Spitalul Universitar de Urgenta Elias-Cardiology

Bucharest, Romania

Actively Recruiting

32

Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laboratory

Bucharest, Romania

Actively Recruiting

33

Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department

Belgrade, Serbia

Actively Recruiting

34

KBC Bezanijska Kosa-Cardiology Department

Belgrade, Serbia

Actively Recruiting

35

KBC Zemun-Cardiology Department

Belgrade, Serbia

Actively Recruiting

36

University Clinical Centre of Serbia-Department for cardiac arrhythmias

Belgrade, Serbia

Actively Recruiting

37

University Clinical Centre of Serbia-Department for invasive electrophysiology

Belgrade, Serbia

Actively Recruiting

38

University Clinical Centre of Serbia-Emergency centre

Belgrade, Serbia

Actively Recruiting

39

University Clinical Centre of Kragujevac-Cardiology Department

Kragujevac, Serbia

Actively Recruiting

40

University Clinical Centre of Nis-Cardiology Department

Niš, Serbia

Actively Recruiting

41

Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY

Alicante, Spain

Actively Recruiting

42

Hospital General Universitario Santa Lucía-CARDIOLOGY

Cartagena, Spain

Actively Recruiting

43

Hospital Valle del Guadalhorce-CARDIOLOGY

Cártama, Spain

Actively Recruiting

44

Hospital General Universitario de Elche-CARDIOLOGY

Elche, Spain

Actively Recruiting

45

Hospital Universitario Virgen de la Victoria-CARDIOLOGY

Málaga, Spain

Actively Recruiting

46

Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA

Murcia, Spain

Actively Recruiting

47

Hospital General Universitario Reina Sofía-CARDIOLOGY

Murcia, Spain

Actively Recruiting

48

Hospital Universitario San Juan de Alicante-CARDIOLOGY

Sant Joan d'Alacant, Spain

Actively Recruiting

49

Hospital Universitario de Tarragona Joan XXIII-Cardiology

Tarragona, Spain

Actively Recruiting

50

Pius Hospital de Valls-Cardiology

Valls, Spain

Actively Recruiting

Loading map...

Research Team

A

Aldo P Maggioni, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Integrated Approach in Frail Older People with Atrial Fibrillation | DecenTrialz