Early Detection and Management of Cardiac Iron Overload in Sickle Cell Disease Using Multimodal Imaging for Improved Clinical Outcomes
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Length of Stay for SCD-Related Complications
研究概览
简要总结
This study tests whether early heart screening and treatment for iron overload in subjects with sickle cell disease can prevent heart problems and reduce hospitalizations.
详细描述
The goal of the study is to detect iron-related heart problems in subjects with sickle cell disease (SCD) through regular cardiac imaging (electrocardiogram, echocardiogram, cardiac MRI) and lab testing every 3 months during the 12 months period. The treatment will be with iron chelation and guideline-directed heart medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years of age
- •Diagnosis of sickle cell disease (any genotype)
- •Serum ferritin levels ≥ 400 ng/mL (up to 80 patients), or less than 400 ng/mL in those who have cardiac symptoms including shortness of breath and lower extremity edema (up to 20 patients)
- •Willingness to undergo regular imaging (echocardiograms, ECG, cardiac MRI)
- •ECOG performance status of 0-1
- •Able to read, understand and provide written informed consent
- •Deemed appropriate for participation by the treating physician
排除标准
- •Unable to schedule and required follow-up visits
- •Medical comorbidities including:
- •Known heart failure
- •Unstable angina
- •Uncontrolled dysrhythmias
- •Acute pulmonary embolism
- •Active infection or severe comorbid conditions that in the view of the investigator would limit participation
- •History of hypersensitivity or contraindication to chelation therapy
- •Severe renal or hepatic impairment
- •Pregnancy of breastfeeding
研究组 & 干预措施
Intervention for Cardiac Iron Overload in Sickle Cell Patients
The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
干预措施: Echocardiography (Device)
Intervention for Cardiac Iron Overload in Sickle Cell Patients
The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
干预措施: Electrocardiogram (ECG) (Device)
Intervention for Cardiac Iron Overload in Sickle Cell Patients
The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
干预措施: Deferoxamine (Drug)
Intervention for Cardiac Iron Overload in Sickle Cell Patients
The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
干预措施: Deferasirox (Drug)
Intervention for Cardiac Iron Overload in Sickle Cell Patients
The study intervention consists of regular cardiac monitoring, iron chelation therapy and guideline-directed medical therapy (GDMT).
干预措施: Deferiprone (Drug)
结局指标
主要结局
Length of Stay for SCD-Related Complications
时间窗: Up to 12 Months
The total number of days spent in the hospital per admission for complications related to SCD.
Incidence of Hospitalization for Sickle Cell Disease Related Complications
时间窗: Up to 12 months
Total number of participants hospitalized for SCD related complications including vaso-occlusive crises, acute chest syndrome and infection detect the impact of early intervention of cardiac iron overload in patients with Sickle Cell Disease
次要结局
- Incidence of Left and/or Right Heart Failure(Up to 12 Months)
- Incidence of Atrial or Ventricular Arrhythmia or Conduction Abnormalities(Up to 12 Months)