Atrial Fibrillation in Beta-Thalassemia

NCT ID: NCT05508932

Last Updated: 2025-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2032-07-01

Brief Summary

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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

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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.

Conditions

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Atrial Fibrillation Thalassemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Beta-thalassemia

Patients with Beta-thalassemia undergoing a cardiological evaluation

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Transfusion-dependent Beta-thalassemia;
2. Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
3. Electrocardiogram performed;
4. Echocardiogram performed.

Exclusion Criteria

1. Age \<18 years;
2. State Of pregnancy;
3. Inability to give informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital of Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Matteo Bertini

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Matteo Bertini

Ferrara, , Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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Matteo Bertini

Role: primary

+39 0532236269

References

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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 Oct 9. doi: 10.1007/s10554-025-03535-2. Online ahead of print.

Reference Type DERIVED
PMID: 41065927 (View on PubMed)

Other Identifiers

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419/2022/Oss/AOUFe

Identifier Type: -

Identifier Source: org_study_id

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