Atrial Fibrillation in Beta-Thalassemia

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05508932

Enrollment

350

Registered

2022-08-19

Start date

2022-09-01

Completion date

2032-07-01

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation, Thalassemia

Keywords

Atrial Fibrillation, Thalassemia, Thalassaemia, Arrhythmia, Hemoglobinopathies

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
Atrial fibrillation	10 years	New onset of Atrial Fibrillation documented at ECG

Secondary

Measure	Time frame	Description
Thromboembolism	10 years	Stroke or peripheral embolization
Epicardial adipose tissue	Baseline	Thickness of fat depot in epicardial region
SGLT2 effect on Hb	6 months	rise in hemoblogin levels
Atrial fibrillation recurrences	10 years	Recurrences of AF during follow-up

Countries

Italy

Outcome results