Atrial Fibrillation in Beta-Thalassemia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Atrial fibrillation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Transfusion-dependent Beta-thalassemia;
- •Follow-Up at the Cardiology Unit of the University Hospital of Ferrara;
- •Electrocardiogram performed;
- •Echocardiogram performed.
排除标准
- •Age <18 years;
- •State Of pregnancy;
- •Inability to give informed consent.
研究组 & 干预措施
Beta-thalassemia
Patients with Beta-thalassemia undergoing a cardiological evaluation
结局指标
主要结局
Atrial fibrillation
时间窗: 10 years
New onset of Atrial Fibrillation documented at ECG
次要结局
- Thromboembolism(10 years)
- Epicardial adipose tissue(Baseline)
- SGLT2 effect on Hb(6 months)
- Atrial fibrillation recurrences(10 years)
研究者
Matteo Bertini
Associate Professor
University Hospital of Ferrara