NCT07572175尚未招募2 期
SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients ≥ 18 years
- •Newly diagnosed lymphoma
- •Scheduled to receive high-dose anthracycline (cumulative dose ≥ 300 mg/m2)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
排除标准
- •Prior anthracycline treatment
- •Previous malignancy requiring any chemotherapy or radiotherapy
- •Previous treatment with SGLT2i (eg due to T2DM) or SGLT1/2i
- •Previous heart failure (HF patients should already be on SGLT2i as per guidelines)
- •LVEF<40% (even in the absence of HF):
- •Pregnancy or breastfeeding
- •Standard contraindication to MRI (claustrophobia, non-MRI compatible devices)
研究者
Carlos Santos-Gallego
Cardiologist, Assistant Professor of Cardiology
Icahn School of Medicine at Mount Sinai
研究点 (1)
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