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 .
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.
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;
Parallel
iABC platform use
Other interventionThe 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.
Impact of iABC on all cause unplanned hospitalization
All-cause unplanned hospitalization
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
Impact of iABC on secondary outcome measures
all-cause mortality
Impact of iABC on secondary outcome measures
all-cause mortality and all-cause (planned and unplanned) hospitalizations
Impact of iABC on secondary outcome measures
new diagnosis of HF or worsening HF requiring hospitalizations
Click on the lead sponsor to view all of their trials.
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
