RecruitingNot Applicable

Integrated Approach in Frail Older People with Atrial Fibrillation

Bulgaria, Denmark, Italy1,250 participantsStarted 2024-04-11

Plain-language 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 .

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Impact of iABC on all cause unplanned hospitalization

Timeframe: 12 months

Trial details

NCT IDNCT06775028

SponsorHeart Care Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

Contact for this trial

Aldo P Maggioni, MD

+390555101211 affirmo@heartcarefoundation.it

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials