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Integrated Approach in Frail Older People with Atrial Fibrillation

RECRUITINGN/ASponsored by Heart Care Foundation
Actively Recruiting
PhaseN/A
SponsorHeart Care Foundation
Started2024-04-11
Est. completion2026-01-31
Eligibility
Age65 Years+
Healthy vol.Accepted

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. 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

Age: 65 Years+Healthy volunteers accepted
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.

Conditions12

Atrial Fibrillation (AF)CKDCOPDCoronary Arterial Disease (CAD)DiabetesDiabetes MellitusHeart DiseaseHeart FailureHypertensionPeripheral Arterial Disease

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