Recruiting

Integrated Approach in Frail Older People with Atrial Fibrillation

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…

ClinicalTrials.gov IDNCT06775028

PhaseNA

Enrollment1250

SponsorHeart Care Foundation

Age65 Years

SexALL

I'm interested View official listing

Conditions studied

Atrial Fibrillation (AF), Hypertension, Coronary Arterial Disease (CAD), Heart Failure, COPD, Peripheral Arterial Disease, CKD, Diabetes Mellitus, Stroke, TIA (Transient Ischemic Attack)

About this study

Interventions

Other: 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.

Primary outcomes

Impact of iABC on all cause unplanned hospitalization (12 months)

Eligibility information

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Study locations

MHAT Haskovo AD-Cardiology, Haskovo, Bulgaria
SHATS Sveti Georgi - Pernik-Cardiology, Pernik, Bulgaria
MBAL Sv. Ivan Rilski-Cardiology, Plovdiv, Bulgaria
UMBAL Sveti Georgi EAD-Clinic of Cardiology, Plovdiv, Bulgaria
UMHAT Pulmed Plovdiv-Cardiology, Plovdiv, Bulgaria
Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology, Sofia, Bulgaria
Acibadem City Clinic UMBAL Cardiovascular Center-CARDIOLOGY, Sofia, Bulgaria
National Heart Hospital-ICCU, Sofia, Bulgaria
Herlev Hospital-Department of Cardiology, Herlev, Denmark
North Denmark Regional Hospital-Department of Cardiology, Hjørring, Denmark

Showing 10 of 50 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.