Integrated Approach in Frail Older People with Atrial Fibrillation

Официальное название

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

Обзор

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 .

Подробное описание

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.

Вмешательства

• Другое iABC platform use
  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.

Первичные конечные точки

• Impact of iABC on all cause unplanned hospitalization [Срок оценки: 12 months]

Вторичные конечные точки (12)

• Impact of iABC on the composite endpoint of non ischemic stroke, transient ischemic attack and cardiovascular death [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Impact of iABC on secondary outcome measures [Срок оценки: 12 months]
• Level of adherence to iABC pathway [Срок оценки: 12 months]
• Impact of iABC on self reported physical activity [Срок оценки: 12 months]
• Level of empowerment and engagement of patient assessed with PHE-S questionnaire [Срок оценки: 12 months]
• Therapy adherence [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 12 центров

• Azienda Ospedaliera S. Anna E S. Sebastiano-Cardiologia Clinica Universitaria — Caserta
• Ospedale Santa Maria Nuova-Cardiologia - Firenze 1 — Florence
• Als Genovese Palazzo Della Salute-Cardiologia Quarto — Genova
• Ospedale Della Misericordia-U.O. Di Cardiologia — Grosseto
• Fondazione Irccs San Gerardo Dei Tintori - Ospedale San Gerardo - U.O.C. Cardiologia — Monza
• Istituti Clinici Scientifici Maugeri Irccs Sede Di Milano-Uo Cure Subacute — Milan
• Ospedale Civile 'Guglielmo Da Saliceto'-Uoc Cardiologia E Utic — Piacenza
• Ospedale Gubbio-Gualdo Tadino-U.O. Di Utic E Cardiologia — Gubbio
• … и ещё 4 центра

Испания · 10 центров

• Hospital General Universitario de Alicante Doctor Balmis-CARDIOLOGY — Alicante
• Hospital General Universitario Santa Lucía-CARDIOLOGY — Cartagena
• Hospital Valle del Guadalhorce-CARDIOLOGY — Cártama
• Hospital General Universitario de Elche-CARDIOLOGY — Elche
• Hospital Universitario Virgen de la Victoria-CARDIOLOGY — Málaga
• Hospital Clínico Universitario Virgen de la Arrixaca-CARDIOLOGÍA — Murcia
• Hospital General Universitario Reina Sofía-CARDIOLOGY — Murcia
• Hospital Universitario San Juan de Alicante-CARDIOLOGY — Sant Joan d'Alacant
• … и ещё 2 центра

Болгария · 8 центров

• MHAT Haskovo AD-Cardiology — Haskovo
• SHATS Sveti Georgi - Pernik-Cardiology — Pernik
• MBAL Sv. Ivan Rilski-Cardiology — Plovdiv
• UMBAL Sveti Georgi EAD-Clinic of Cardiology — Plovdiv
• UMHAT Pulmed Plovdiv-Cardiology — Plovdiv
• Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology — Sofia
• Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY — Sofia
• National Heart Hospital-ICCU — Sofia

Румыния · 8 центров

• Spitalul Clinic Colentina-Cardiology — Bucharest
• Spitalul Clinic Colentina-Internal Medicine — Bucharest
• Spitalul Clinic Coltea-Internal Medicine and Cardiology — Bucharest
• Spitalul Clinic de Urgenta 'Bagdasar-Arseni'-Cardiology — Bucharest
• Spitalul Clinic de Urgenta Bucuresti-Cardiology — Bucharest
• Spitalul Clinic Prof.Dr.Th.Burghele-Internal Medicine and Cardiology — Bucharest
• Spitalul Universitar de Urgenta Elias-Cardiology — Bucharest
• Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila-Cardiac Function Laborato — Bucharest

Сербия · 8 центров

• Institute for Cardiovascular Diseases Dedinje-Pacemaker and electrophysiology department — Belgrade
• KBC Bezanijska Kosa-Cardiology Department — Belgrade
• KBC Zemun-Cardiology Department — Belgrade
• University Clinical Centre of Serbia-Department for cardiac arrhythmias — Belgrade
• University Clinical Centre of Serbia-Department for invasive electrophysiology — Belgrade
• University Clinical Centre of Serbia-Emergency centre — Belgrade
• University Clinical Centre of Kragujevac-Cardiology Department — Kragujevac
• University Clinical Centre of Nis-Cardiology Department — Niš

Дания · 4 центра

• Herlev Hospital-Department of Cardiology — Herlev
• North Denmark Regional Hospital-Department of Cardiology — Hjørring
• Horsens Regional Hospital-Department of Medicine — Horsens
• Silkeborg Regional Hospital-Diagnostic Centre, University Clinic for Development of Innova — Silkeborg

Публикации

• 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 polyme PMID 41580107

Идентификаторы

NCT: NCT06775028 · K23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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