Atrial Fibrillation in Beta-Thalassemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation, Thalassemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
The study aims to evaluate the clinical, laboratory and instrumental differences that exist between beta-thalassemia patients with atrial fibrillation and those not affected by arrhythmia.
Detailed description
Observational, retrospective and prospective, single-center study, which involves the collection of clinical, laboratory, electrocardiographic and imaging data of patients with major or intermediate thalassemia who have performed, from 2012 to 2022, or will perform in the next 10 years, a cardiological evaluation at the Cardiology Unit of the University Hospital of Ferrara. Patients will be divided into two groups: thalassemia patients with atrial fibrillation (paroxysmal, persistent or permanent) and thalassemia patients with no history of atrial fibrillation.
The objective of the study is to evaluate whether there is a different prevalence of the characteristics analyzed among these patient populations.
As secondary outcome, the effect of SGLT2-inhibitors (empaglifozin, dapaglifozin, ...) will be evaluated.
Primary outcome measures
- Atrial fibrillation [Time frame: 10 years]
Secondary outcome measures (4)
- Thromboembolism [Time frame: 10 years]
- Epicardial adipose tissue [Time frame: Baseline]
- SGLT2 effect on Hb [Time frame: 6 months]
- Atrial fibrillation recurrences [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- Transfusion-dependent Beta-thalassemia;
- Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
- Electrocardiogram performed;
- Echocardiogram performed.
Exclusion criteria
- Age <18 years;
- State Of pregnancy;
- Inability to give informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- Matteo Bertini — Ferrara
Publications
- Marchini F, Mele M, Marchetti E, Rotondo L, Frascaro F, Malagu M, Pavasini R, Tonet E, Serenelli M, Cossu A, Longo F, Lo Monaco M, Bertella E, Campo G, Bertini M. Assessing Cardiac Mechanical Dysfunction in Transfusion-Dependent beta-Thalassemia With History of Atrial Fibrillation: The Role of Speckle Tracking Echocardiography. Echocardiography. 2026 Feb;43(2):e70408. doi: 10.1111/echo.70408. PMID 41674122
- Malagu M, Marchini F, Longo F, Zuin M, Orazio G, Capanni A, Berloni ML, Frascaro F, Tonet E, Cossu A, Culcasi M, Bonsi B, Balla C, Vitali F, Bertini M. Association between epicardial adipose tissue and transfusion-dependent beta-thalassemia. Int J Cardiovasc Imaging. 2025 Nov;41(11):2255-2263. doi: 10.1007/s10554-025-03535-2. Epub 2025 Oct 9. PMID 41065927
Identifiers
NCT: NCT05508932 · 419/2022/Oss/AOUFe