Integrated care for older patients with atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates a structured multidisciplinary approach called iABC, designed to improve the management of elderly patients with atrial fibrillation (AF) who also have multiple health conditions. The iABC group will follow a specific pathway focused on preventing strokes, managing symptoms, and optimizing care for associated comorbidities. The study will compare this integrated approach to usual clinical care in a controlled setting across several countries, including Bulgaria, Denmark, Italy, Romania, Serbia, and Spain. By randomizing healthcare centers to either the iABC intervention or standard care, the study aims to provide robust evidence on the effectiveness of this holistic management strategy.

Why it matters

Who can join: the full rules

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.

Where it's running

• MHAT Haskovo AD-Cardiology
  Haskovo, Bulgaria Recruiting
• SHATS Sveti Georgi - Pernik-Cardiology
  Pernik, Bulgaria Recruiting
• MBAL Sv. Ivan Rilski-Cardiology
  Plovdiv, Bulgaria Recruiting
• UMBAL Sveti Georgi EAD-Clinic of Cardiology
  Plovdiv, Bulgaria Recruiting
• UMHAT Pulmed Plovdiv-Cardiology
  Plovdiv, Bulgaria Recruiting
• Acibadem City Clinic Tokuda Hospital-Dept of Electrophysiology Clinic of Cardiology
  Sofia, Bulgaria Recruiting

Study contacts

• Study coordinator: Aldo P Maggioni, MD
• Email: affirmo@heartcarefoundation.it
• Phone: +390555101211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.