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Integrated care for older patients with atrial fibrillation

AFFIRMO - Atrial Fibrillation Integrated Approach in Frail, Multimorbid and Polymedicated Older People

Not applicable Interventional Heart Care Foundation · NCT06775028

This study is testing a new team-based care approach for older patients with atrial fibrillation and other health issues to see if it helps them manage their condition better than regular care.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1250 (estimated)
Ages65 Years and up
SexAll
SponsorHeart Care Foundation Academic / other
Locations50 sites (Haskovo and 49 other locations)
Trial IDNCT06775028 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are outpatients aged 65 and older with a confirmed diagnosis of atrial fibrillation and at least one additional long-term health condition.

Not a fit: Patients with mechanical heart valves, severe mitral stenosis, or those with a life expectancy of less than 12 months may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the quality of life and clinical outcomes for elderly patients with atrial fibrillation and multiple comorbidities.

How similar studies have performed: Other studies have shown promise with integrated care approaches for managing atrial fibrillation, suggesting potential for success in this novel application.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Haskovo and 49 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Atrial FibrillationHypertensionCoronary Arterial DiseaseHeart FailureCOPDPeripheral Arterial DiseaseCKDDiabetes Mellitus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.