NCT06775028 Integrated Approach in Frail Older People with Atrial Fibrillation
| NCT ID | NCT06775028 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart Care Foundation |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,250 participants |
| Start Date | 2024-04-11 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,250 participants in total. It began in 2024-04-11 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 .
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06775028 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06775028 currently recruiting?
Yes, NCT06775028 is actively recruiting participants. Contact the research team at affirmo@heartcarefoundation.it for enrollment information.
Where is the NCT06775028 trial being conducted?
This trial is being conducted at Haskovo, Bulgaria, Pernik, Bulgaria, Plovdiv, Bulgaria, Plovdiv, Bulgaria and 11 additional locations.
Who is sponsoring the NCT06775028 clinical trial?
NCT06775028 is sponsored by Heart Care Foundation. The trial plans to enroll 1,250 participants.
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