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NCT Number: NCT05508932

Atrial Fibrillation in Beta-Thalassemia

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.

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Key information

Conditions

Atrial Fibrillation Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Arrhythmias, Cardiac Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Pathologic Processes Pathological Conditions, Signs and Symptoms Thalassemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Atrial fibrillation

    Time frame: 10 years

    New onset of Atrial Fibrillation documented at ECG

Secondary outcomes

  1. Thromboembolism

    Time frame: 10 years

    Stroke or peripheral embolization

  2. Epicardial adipose tissue

    Time frame: Baseline

    Thickness of fat depot in epicardial region

  3. SGLT2 effect on Hb

    Time frame: 6 months

    rise in hemoblogin levels

  4. Atrial fibrillation recurrences

    Time frame: 10 years

    Recurrences of AF during follow-up

Sponsors and collaborators

Lead sponsor

University Hospital of Ferrara

Other

Registry information

Important dates

Study start
2022
Primary completion
2032
Study completion
2032
First posted
Aug 19, 2022
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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