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Atrial Fibrillation (AF)AFFIRMONCT06775028

Integrated Approach in Frail Older People with Atrial Fibrillation

A study testing iABC platform use in people with Atrial Fibrillation (AF) and Hypertension, run by Heart Care Foundation at 50 sites in 6 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
iABC platform use
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,250 participants
Where
50 sitesin 6 countries
Study dates
11 Apr 2024to 31 Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • Mechanical prosthetic heart valve or moderate/severe mitral stenosis;
  • 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.

Trial locations and contacts

50 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Aldo P Maggioni, MD contact

+390555101211

affirmo@heartcarefoundation.it

50 sites in 6 countries

Italy12 sites, 12 recruiting

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

    Caserta, CE, 81100

    Paolo Calabro', MD

    Recruiting

  • Ospedale Santa Maria Nuova-Cardiologia - Firenze 1

    Florence, FI, 50122

    Alessandro Paoletti Perini

    Recruiting

  • Als Genovese Palazzo Della Salute-Cardiologia Quarto

    Genova, GE, 16100

    Maria Luisa Biorci, MD

    Recruiting

  • Ospedale Della Misericordia-U.O. Di Cardiologia

    Grosseto, GR, 58100

    Luigi Addonisio, MD

    Recruiting

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

    Gubbio, PG, 06024

    Deborah Cosmi, MD

    Recruiting

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

    Milan, MI, 20138

    Marco Proietti, MD

    Recruiting

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

    Monza, MB, 20900

    Elena Pazzi, MD

    Recruiting

  • Aou Federico Ii-Medicina Metabolico-Riabilitativa

    Naples, 80131

    Alberto Maria Marra, MD

    Recruiting

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

    Piacenza, PC, 29100

    Daniela Aschieri, MD, +390523303209, d.aschieri@ausl.pc.it

    Recruiting

  • Policlinico Umberto Primo-Medicina Interna E Immunologia Clinica

    Roma, RM, 00161

    Stefania Basili, MD

    Recruiting

  • Azienda Ospedaliera Santa Maria-Medicina Interna

    Terni, TR, 05100

    Giacomo Pucci, MD

    Recruiting

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

    Udine, UD, 33100

    Marzia De Biasio, MD

    Recruiting

Other trials in Italy

Spain10 sites, 10 recruiting

  • Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY

    Alicante

    AMAYA GARCÍA-FERNÁNDEZ, MD

    Recruiting

  • Hospital General Universitario Santa Lucía-CARDIOLOGY

    Cartagena

    IGNACIO GIL-ORTEGA, MD

    Recruiting

  • Hospital Valle del Guadalhorce-CARDIOLOGY

    Cártama

    JORGE RODRÍGUEZ CAPITÁN, MD

    Recruiting

  • Hospital General Universitario de Elche-CARDIOLOGY

    Elche

    ANTONIO GARCÍA-HONRUBIA, MD

    Recruiting

  • Hospital Universitario Virgen de la Victoria-CARDIOLOGY

    Málaga

    ALEJANDRO ISIDORO PÉREZ CABEZA, MD

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA

    Murcia

    FRANCISCO MARIN, MD

    Recruiting

  • Hospital General Universitario Reina Sofía-CARDIOLOGY

    Murcia

    TOMÁS VICENTE VERA, MD

    Recruiting

  • Hospital Universitario San Juan de Alicante-CARDIOLOGY

    Sant Joan d'Alacant

    JOSE MORENO ARRIBAS, MD

    Recruiting

  • Hospital Universitario de Tarragona Joan XXIII-Cardiology

    Tarragona

    JOSÉ LUÍS FERREIRO-GUTIÉRREZ, MD

    Recruiting

  • Pius Hospital de Valls-Cardiology

    Valls

    LEYDIMAR ADEL ANMAD SHIHADEH MUSA, MD

    Recruiting

Other trials in Spain

Bulgaria8 sites, 8 recruiting

  • MHAT Haskovo AD-Cardiology

    Haskovo

    ANTONY GOGOV, MD

    Recruiting

  • SHATS Sveti Georgi - Pernik-Cardiology

    Pernik

    KOSTADIN KICHUKOV, MD

    Recruiting

  • MBAL Sv. Ivan Rilski-Cardiology

    Plovdiv

    KRASTYU PENCHEV, MD

    Recruiting

  • UMBAL Sveti Georgi EAD-Clinic of Cardiology

    Plovdiv

    MARIYA TOKMAKOVA, MD

    Recruiting

  • UMHAT Pulmed Plovdiv-Cardiology

    Plovdiv

    VLADIMIR IVANOV, MD

    Recruiting

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

    Sofia

    VASSIL TRAYKOV, MD

    Recruiting

  • Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY

    Sofia

    ISKREN GARVANSKI, MD

    Recruiting

  • National Heart Hospital-ICCU

    Sofia

    ELENA KOSTOVA-DIMITROVA, MD

    Recruiting

Other trials in Bulgaria

Romania8 sites, 8 recruiting

  • Spitalul Clinic Colentina-Cardiology

    Bucharest

    ANCA RODICA DAN, MD

    Recruiting

  • Spitalul Clinic Colentina-Internal Medicine

    Bucharest

    CRISTIAN RASVAN BAICUS, MD

    Recruiting

  • Spitalul Clinic Coltea-Internal Medicine and Cardiology

    Bucharest

    ILINCA MIHAELA SAVULESCU-FIEDLER, MD

    Recruiting

  • Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology

    Bucharest

    CRINA SINESCU, MD

    Recruiting

  • Spitalul Clinic de Urgenta Bucuresti-Cardiology

    Bucharest

    ALEXANDRU SCAFA-UDRISTE, MD

    Recruiting

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

    Bucharest

    ANA MARIA BALAHURA, MD

    Recruiting

  • Spitalul Universitar de Urgenta Elias-Cardiology

    Bucharest

    SERBAN BALANESCU, MD

    Recruiting

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

    Bucharest

    SILVIU STANCIU, MD

    Recruiting

Other trials in Romania

Serbia8 sites, 8 recruiting

  • Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department

    Belgrade

    DEJAN KOJIC, MD

    Recruiting

  • KBC Bezanijska Kosa-Cardiology Department

    Belgrade

    MARIJA ZDRAVKOVIC, MD

    Recruiting

  • KBC Zemun-Cardiology Department

    Belgrade

    RADOSAV VIDAKOVIC, MD

    Recruiting

  • University Clinical Centre of Serbia-Department for cardiac arrhythmias

    Belgrade

    TATJANA POTPARA, MD

    Recruiting

  • University Clinical Centre of Serbia-Department for invasive electrophysiology

    Belgrade

    NEBOJSA MUJOVIC, MD

    Recruiting

  • University Clinical Centre of Serbia-Emergency centre

    Belgrade

    TANJA JOZIC, MD

    Recruiting

  • University Clinical Centre of Kragujevac-Cardiology Department

    Kragujevac

    STEFAN SIMOVIC, MD

    Recruiting

  • University Clinical Centre of Nis-Cardiology Department

    Niš

    TOMISLAV KOSTIC, MD

    Recruiting

Other trials in Serbia

Denmark4 sites, 4 recruiting

  • Herlev Hospital-Department of Cardiology

    Herlev

    MORTEN K LAMBERTS, MD

    Recruiting

  • North Denmark Regional Hospital-Department of Cardiology

    Hjørring

    ALBERT MARNI JOENSEN, MD

    Recruiting

  • Horsens Regional Hospital-Department of Medicine

    Horsens

    KAREN KAAE DODT, MD

    Recruiting

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

    Silkeborg

    LARS FROST, MD

    Recruiting

Other trials in Denmark

About this study

Official title: AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People

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 .

Read the detailed description

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.

Being tested
iABC platform use
Keywords
iABC, Atrial Fibrillation, Cluster Trial
Medical subject headings
Atrial Fibrillation, Hypertension, Heart Failure, Pulmonary Disease, Chronic Obstructive, Peripheral Arterial Disease, Diabetes Mellitus, Stroke, Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iABC platform useOther

    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.

Study groups in NCT06775028
Study groupRoleWhat they receive
Quality-improvement intervention (iABC)ExperimentalThe 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.
Receives: Other: iABC platform use
Usual careNo interventionPatients followed in the centers randomized to the control arm will be managed by usual care in accordance with local clinical guidance

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Impact of iABC on all cause unplanned hospitalization

    All-cause unplanned hospitalization

    Measured: 12 months

Secondary outcomes (12)

  1. 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

    Measured: 12 months

  2. Impact of iABC on secondary outcome measures

    all-cause mortality

    Measured: 12 months

  3. Impact of iABC on secondary outcome measures

    all-cause mortality and all-cause (planned and unplanned) hospitalizations

    Measured: 12 months

  4. Impact of iABC on secondary outcome measures

    new diagnosis of HF or worsening HF requiring hospitalizations

    Measured: 12 months

  5. Impact of iABC on secondary outcome measures

    quality of life assessed with EQ-5D-5L questionnaire

    Measured: 12 months

  6. Impact of iABC on secondary outcome measures

    major bleeds defined according to the ISTH definitions

    Measured: 12 months

  7. Impact of iABC on secondary outcome measures

    intracranial bleeds

    Measured: 12 months

  8. Impact of iABC on secondary outcome measures

    occurrence of renal dysfunction or worsening renal function

    Measured: 12 months

  9. Level of adherence to iABC pathway

    Level of adherence to iABC pathway will be evaluated by:

    • the number of accesses to the APP.
    • daily patient's adherence to oral anticoagulant therapy,
    • weekly blood pressure and weight self-measurements input
    • weekly AF symptoms related questionnaires completion

    Measured: 12 months

  10. Impact of iABC on self reported physical activity

    Impact of iABC on self reported physical activity

    Measured: 12 months

  11. Level of empowerment and engagement of patient assessed with PHE-S questionnaire

    Level of empowerment and engagement of patient assessed with PHE-S questionnaire

    Measured: 12 months

  12. Therapy adherence

    Will be evaluated by persistence medical treatment at 12 month follow-up as reported in the e-CRF

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2025
  2. Study start11 Apr 2024
  3. Primary completion31 Jan 2026 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cluster randomized trial
Masking
None (open label)
Enrolment
1,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06775028
Sponsor's protocol ID
K23
Acronym
AFFIRMO
Status last verified
Jan 2025
First submitted
31 Dec 2024
Last updated
14 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lip GYH, Proietti M, Ainsworth J, Dan GA, Frost L, Graffigna G, Lane DA, Lucci D, Fabbri G, Marin F, O'Flaherty M, Petrovic M, Potpara TS, Proietti R, Sanaullah A, Tokmakova M, Vetrano DL, Johnsen SP, Maggioni AP; AFFIRMO Study Investigators and Consortiumv; AFFIRMO Study Investigators and Consortium. 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 Aug 30;70:101832. doi: 10.1016/j.lanepe.2026.101832. eCollection 2026 Nov.

    PubMed 42819749

  • 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.

    PubMed 41580107

Questions about this trial

What is this clinical trial studying?

A study testing iABC platform use in people with Atrial Fibrillation (AF) and Hypertension, run by Heart Care Foundation at 50 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Italy, Spain, Bulgaria, Romania, Serbia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aldo P Maggioni, MD (+390555101211, affirmo@heartcarefoundation.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of iABC on all cause unplanned hospitalization (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06775028, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.

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