Integrated Approach in Frail Older People with Atrial Fibrillation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorHeart Care Foundation

About this trial

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 .

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • iABC platform use

Treatment groups

1,250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Heart Care Foundation

Lead sponsor

Aalborg University

Collaborator

University of Belgrade

Collaborator

Universidad de Murcia

Collaborator

Carol Davila University of Medicine and Pharmacy

Collaborator

Plovdiv Medical University

Collaborator

University of Liverpool

Collaborator