Sotagliflozin for Cardiotoxicity
(SPARTACUS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests sotagliflozin to determine if it can prevent heart damage caused by certain cancer treatments, specifically anthracyclines, in people with newly diagnosed lymphoma. Sotagliflozin targets specific proteins to help protect the heart. Participants will receive either the drug or a placebo (a pill with no active medication) to compare results. Those who might be a good fit for this trial include individuals with newly diagnosed lymphoma who are about to start high-dose anthracycline treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are already on SGLT2 inhibitors, you cannot participate in the trial.
Is there any evidence suggesting that sotagliflozin is likely to be safe for humans?
Previous studies have generally found sotagliflozin to be well-tolerated, though some side effects require attention. Commonly reported issues include urinary tract infections, diarrhea, and a serious diabetes-related condition called diabetic ketoacidosis. These side effects are similar to those of other drugs in the same category. Large studies involving over 30,000 patients have shown that sotagliflozin can effectively lower the risk of heart problems, such as strokes and heart attacks, particularly in individuals with diabetes and kidney issues. While some risks exist, the benefits may outweigh them for certain patients. Always consult a healthcare provider to determine how this treatment might fit into a health plan.12345
Why do researchers think this study treatment might be promising for cardiotoxicity?
Sotagliflozin is unique because it offers a different approach to managing cardiotoxicity by targeting the sodium-glucose co-transporter (SGLT) pathways, specifically SGLT1 and SGLT2. Unlike traditional treatments for cardiotoxicity, which often focus on managing symptoms or preventing further damage, sotagliflozin works to protect heart function through its dual action on glucose and sodium reabsorption. Researchers are excited about this treatment because it could provide a more comprehensive protective effect on the heart, potentially reducing the risk of heart failure and improving outcomes for patients experiencing cardiotoxic effects.
What evidence suggests that sotagliflozin might be an effective treatment for cardiotoxicity?
Research has shown that sotagliflozin can significantly lower the risk of heart problems. For example, one study found it reduced heart attacks from 2.7 to 1.8 events per 100 people each year. It also helps reduce hospital visits and improves heart function in people with heart failure. Additionally, sotagliflozin has decreased deaths from heart issues and hospital stays due to heart failure. In this trial, participants will receive either sotagliflozin or a placebo to evaluate its potential in protecting the heart from damage caused by some cancer treatments.36789
Who Is on the Research Team?
Carlos G Santos-Gallego, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Santos-Gallego, MD
Principal Investigator
Icahn School of Medicine at Mount Sinai
Are You a Good Fit for This Trial?
This trial is for adults (18 or older) who have just been diagnosed with lymphoma and are about to start high-dose anthracycline chemotherapy. Participants need to be well enough for daily activities, as measured by a standard scale.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Sotagliflozin 400mg per day or a matching placebo to prevent anthracycline-related cardiotoxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of cardiac function and biomarkers
What Are the Treatments Tested in This Trial?
Interventions
- Sotagliflozin
Trial Overview
The study compares sotagliflozin, a medication that blocks certain sugar transporters in the body, against a placebo. The goal is to see if sotagliflozin can help prevent heart damage caused by chemotherapy.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Sotagliflozin 400mg per day orally
Matching Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Icahn School of Medicine at Mount Sinai
Lead Sponsor
American Heart Association
Collaborator
Citations
Meta‐analysis of sotagliflozin, a dual sodium‐glucose ... - PMC
The SOLOIST‐WHF trial demonstrated that sotagliflozin significantly reduced the risk of cardiovascular death, HF hospitalization and urgent HF ...
Effect of sotagliflozin on major adverse cardiovascular events
Additionally, sotagliflozin significantly reduced the rate of myocardial infarction (1·8 events per 100 person-years vs 2·7 events per 100 ...
3.
investors.lexpharma.com
investors.lexpharma.com/news-releases/news-release-details/clinical-data-demonstrating-efficacy-sotagliflozin-preserved/Clinical Data Demonstrating Efficacy of Sotagliflozin in ...
Treatment with sotagliflozin resulted in statistically significant improvements in left ventricular mass, diastolic function, capacity for a six ...
D-27 | Clinical Efficacy of Sotagliflozin in Cardiovascular ...
Sotagliflozin showed promising results in terms of risk reduction in urgent visits for HF, hospitalizations, and death from CV causes.
Effect of Sotagliflozin on Cardiovascular Events in Patients ...
Among patients hospitalized with HF, initiation of sotagliflozin prior to discharge appeared to improve outcomes within 90 days. In the pooled ...
Sotagliflozin in Patients with Diabetes and Recent ...
The rate of death from cardiovascular causes was 10.6 in the sotagliflozin group and 12.5 in the placebo group (hazard ratio, 0.84; 95% CI, 0.58 ...
Effect of Sotagliflozin on Cardiovascular and Renal Events ...
The results of this trial indicate that sotagliflozin has salutary effects on CV outcomes among patients with T2DM and CKD. The benefit was ...
Cardiovascular benefits and safety of sotagliflozin in type 2 ...
Safety outcomes are urinary tract infection, diarrhea, and diabetic ketoacidosis. Results: Eleven studies with 30,952 patients were included.
Effects of Sotagliflozin on Health Status in Patients With ...
Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.