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
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported