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Search / Trial NCT06775028

Integrated Approach in Frail Older People with Atrial Fibrillation

Launched by HEART CARE FOUNDATION · Jan 9, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

I Abc Atrial Fibrillation Cluster Trial

ClinConnect Summary

This clinical trial, called the Integrated Approach in Frail Older People with Atrial Fibrillation, is designed to see if a new method of managing older patients with atrial fibrillation (AF) and other long-term health conditions can improve their overall health and quality of life. The study will compare this new approach, known as the iABC method, with the usual care these patients receive. The iABC method focuses on three main goals: preventing strokes through proper medication, managing symptoms better, and taking care of other related health issues like heart disease and diabetes.

To participate in this study, you need to be at least 65 years old and have been diagnosed with atrial fibrillation as well as one or more other long-term health conditions, such as high blood pressure or diabetes. Participants can expect regular check-ups and support from a team of healthcare professionals who will help manage their conditions. The trial is currently looking for patients in several European countries, including Bulgaria, Denmark, Italy, Romania, Serbia, and Spain. It's important to note that some patients may not be eligible if they have certain heart conditions or serious illnesses that could affect their participation.

Gender

ALL

Eligibility 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.

About Heart Care Foundation

The Heart Care Foundation is a leading nonprofit organization dedicated to advancing cardiovascular health through innovative research and clinical trials. Committed to enhancing patient outcomes, the Foundation collaborates with medical institutions and experts to explore cutting-edge therapies and interventions for heart-related conditions. By fostering a multidisciplinary approach and prioritizing patient-centered care, the Heart Care Foundation aims to contribute significantly to the understanding and treatment of cardiovascular diseases, ultimately improving the quality of life for individuals affected by these conditions.

Locations

Monza, Mb, Italy

Haskovo, , Bulgaria

Pernik, , Bulgaria

Plovdiv, , Bulgaria

Plovdiv, , Bulgaria

Plovdiv, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Herlev, , Denmark

Hjoerring, , Denmark

Horsens, , Denmark

Silkeborg, , Denmark

Caserta, Ce, Italy

Firenze, Fi, Italy

Genova, Ge, Italy

Grosseto, Gr, Italy

Milano, Mi, Italy

Piacenza, Pc, Italy

Gubbio, Pg, Italy

Roma, Rm, Italy

Terni, Tr, Italy

Udine, Ud, Italy

Napoli, , Italy

Bucuresti, , Romania

Bucuresti, , Romania

Bucuresti, , Romania

Bucuresti, , Romania

Bucuresti, , Romania

Bucuresti, , Romania

Bucuresti, , Romania

Bucuresti, , Romania

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Belgrade, , Serbia

Kragujevac, , Serbia

Nis, , Serbia

Alicante, , Spain

Cartagena, , Spain

Cartama, , Spain

Elche, , Spain

Malaga, , Spain

Murcia, , Spain

Murcia, , Spain

Sant Joan D'alacant, , Spain

Tarragona, , Spain

Valls, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported