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Sotagliflozin as Prevention of Anthracycline-Related Cardiotoxicity (SPARTACUS)

2026年4月30日 更新者：Carlos Santos-Gallego、Icahn School of Medicine at Mount Sinai

SPARTACUS Trial (Sotagliflozin as Prevention of Antracycline-Related Toxicity in Adipose, Cardiac and mUskuloSkeletal Tissues)

This project aims to determine the benefits of the dual SGLT1/2 inhibition as prophylactic treatment to prevent anthracycline-related cardiotoxicity.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

60

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • New York
      • New York、New York、美国、10029
        • Icahn School of Medicine at Mount Sinai
        • 首席研究员：
          • Carlos G Santos-Gallego

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：预防
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
匹配安慰剂
药品：Placebo
Placebo starting prior to the first scheduled anthracycline infusion
有源比较器：Sotagliflozin
Sotagliflozin 400mg per day orally
药品：Sotagliflozin
Sotagliflozin 400mg starting prior to the first scheduled anthracycline infusion

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Left Ventricular Ejection Fraction (LVEF) by Cardiac MRI
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LVEF is a measure of contractility of the heart (strength of contraction). Normal values are between 55-65%. It is the most widely used parameter by physicians worldwide to measure cardiac contractility.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

次要结果测量

结果测量
措施说明
大体时间
Longitudinal Strain of Left Ventricle (LV)
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Longitudinal strain is the deformation of a material per unit length, defined as the ratio of change in length to the original length in the direction of an applied load. It measures how much an object stretches (tensile) or compresses (compressive) along its axis Longitudinal strain is an echocardiographic technique that quantifies the percentage of systolic shortening of the heart muscle from base to apex. It is a highly sensitive indicator of left ventricular function, detecting subclinical, early myocardial dysfunction (e.g., in cardio-oncology) often before the ejection fraction (LVEF) drops. Normal GLS values are typically >18%.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LVEF by 3D-Echocardiography
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LVEF is a measure of contractility of the heart (strength of contraction). Normal values are between 55-65%. It is the most widely used parameter by physicians worldwide to measure cardiac contractility.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV Volumes by MRI
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV volumes measure how enlarged the heart is. Chemotherapy destroys cardiac muscle and enlarges the heart (ie. increases LV volumes). The higher the LV volumes, the more damage by chemotherapy.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV Mass by MRI
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV mass measures the amount of cardiac muscle. Chemotherapy destroys cardiac muscle. The lower the LV mass, the more damage by chemotherapy.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
LV Longitudinal Strains by MRI
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Longitudinal strain is the deformation of a material per unit length, defined as the ratio of change in length to the original length in the direction of an applied load. It measures how much an object stretches (tensile) or compresses (compressive) along its axis Longitudinal strain is an echocardiographic technique that quantifies the percentage of systolic shortening of the heart muscle from base to apex. It is a highly sensitive indicator of left ventricular function, detecting subclinical, early myocardial dysfunction (e.g., in cardio-oncology) often before the ejection fraction (LVEF) drops. Normal GLS values are typically >18%.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
6-Minute Walk Test (6MWT)
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
The 6MWT assesses endurance and ability to walk over longer distances. The 6MWT was first described as a field test for physical fitness in 1963 and then as a 12-minute walk test in people with chronic bronchitis. The 6MWT was found to perform as well as the 12-minute walk, and is now used to assess the submaximal level of functional performance at a similar level required for daily physical activities.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
NT-ProBNP
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
NT-ProBNP is a plasma biomarker of cardiac stress, cardiac tension and severity of heart failure. The higher the NT-ProBNP level, the more severe the heart failure induced by chemotherapy.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Troponin I
大体时间：Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.
Troponin I is a plasma biomarker of cardiac injury and cardiac damage. The higher the troponin levels, the more cardiac damage induced by chemotherapy.
Baseline and end of study, one month after completion of anthracycline treatment, up to 9-10 months.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Icahn School of Medicine at Mount Sinai

合作者

American Heart Association

调查人员

  • 首席研究员：Carlos G Santos-Gallego, MD、Icahn School of Medicine at Mount Sinai
  • 首席研究员：Santos-Gallego, MD、Icahn School of Medicine at Mount Sinai

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2029年6月1日

研究完成 (估计的)

2029年10月1日

研究注册日期

首次提交

2026年4月30日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月7日

研究记录更新

最后更新发布 (实际的)

2026年5月7日

上次提交的符合 QC 标准的更新

2026年4月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • GCO 25-0408

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD 共享时间框架

Beginning 9 months and ending 36 months following article publication.

IPD 共享访问标准

Researchers who provide a methodologically sound proposal. For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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