Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines

Launched by MARIA SKLODOWSKA-CURIE NATIONAL RESEARCH INSTITUTE OF ONCOLOGY · Mar 5, 2022

Keywords

ClinConnect Summary

The EMPACT study is a clinical trial that is investigating whether a medication called empagliflozin can help prevent heart damage in cancer patients who are receiving certain types of chemotherapy known as anthracyclines. This trial is open to adults who have been diagnosed with cancer and are set to receive high doses of anthracyclines, but do not have a history of heart failure. To participate, patients should be between 18 and 74 years old and have a good heart function, which means their heart's pumping ability is normal.

Participants in the trial will be randomly assigned to take either empagliflozin or a placebo (a pill that looks the same but has no active medication) once a day. They will undergo regular heart tests, including echocardiograms (ultrasound of the heart) and magnetic resonance imaging (MRI), to monitor their heart health throughout the study. This research aims to determine if empagliflozin can protect the heart during chemotherapy, potentially leading to better outcomes for patients undergoing cancer treatment. If you're interested in participating, it is important to discuss it with your healthcare provider to see if you meet the eligibility criteria.

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ALL

Eligibility criteria

• • The study will include patients with diagnosed cancer, diagnosed and qualified for further systemic treatment at the National Institute of Oncology in Warsaw. Patients must give informed and voluntary consent to participate in the study and meet all the conditions for inclusion in the study
• Inclusion Criteria:
• • 1. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
• • 2. Age ≥18 years at the time of signing the informed consent.
• • 3. Known neoplastic disease prior to the initiation of chemotherapy with a high dose of anthracyclines (doxorubicin ≥ 240 mg / m2 b.w. or epirubicin ≥ 540 mg / m2 b.w.)
• • 4. No history of heart failure (left ventricular ejection fraction ≥ 50% as assessed by echocardiography).
• • 5. Women of child-bearing age must have a negative serum or urine pregnancy test.
• • 6. All males and females must consent to the use of effective contraception throughout the study period and after study medication is discontinued.
• • 7. Sexually active women of childbearing potential must use 2 effective methods of contraception (abstinence, IUD, oral contraceptive or double barrier device) from informed consent and for at least 6 months after study drug discontinuation
• • 8. Sexually active men and their sexual partners must use effective methods of contraception from the moment they sign their informed consent to participate in the study and for at least 3 months after discontinuation of the study drug.
• Exclusion Criteria:
• • 1. History of heart failure
• • 2. Left ventricle systolic dysfunction assessed by echocardiography (LVEF \<50%)
• • 3. Significant valve disease
• • 4. Previous chemotherapy or radiation to the chest
• • 5. Symptomatic hypotension and / or SBP \<100 mmHg at Visit 1 or Visit 2
• • 6. Liver disease, as determined by ALT, AST, or alkaline phosphatase levels above 3 x upper limit of normal (ULN) at visit 1.
• • 7. Renal impairment, defined as eGFR \<20 mL / min / 1.73 m2 or dialysis requirement, as determined at Visit 1.
• • 8. History of ketoacidosis
• • 9. Gastrointestinal surgery or gastrointestinal disturbance that could impair drug absorption
• • 10. Presence of any disease with a life expectancy \<1 year in the opinion of the investigator.
• • 11. Treatment with any SGLT-2 inhibitor for up to 3 months prior to study enrollment.
• • 12. Pregnancy or breastfeeding
• • 13. Drug or alcohol abuse
• • 14. Suspected non-compliance and irregular use of study drug
• • 15. Inability to perform CMR, e.g. claustrophobia, weight\> 120 kg, etc.