Status:
RECRUITING
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
Cardiotoxicity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevent...
Detailed Description
Malignant neoplasms are the second most common cause of death in Poland. Cancer mortality decreased by 27% over the past 25 years. Improved survival in cancer patients is related to several factors, s...
Eligibility Criteria
Inclusion
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
- Age ≥18 years at the time of signing the informed consent.
- 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.)
- No history of heart failure (left ventricular ejection fraction ≥ 50% as assessed by echocardiography).
- Women of child-bearing age must have a negative serum or urine pregnancy test.
- All males and females must consent to the use of effective contraception throughout the study period and after study medication is discontinued.
- 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
- 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
- History of heart failure
- Left ventricle systolic dysfunction assessed by echocardiography (LVEF \<50%)
- Significant valve disease
- Previous chemotherapy or radiation to the chest
- Symptomatic hypotension and / or SBP \<100 mmHg at Visit 1 or Visit 2
- Liver disease, as determined by ALT, AST, or alkaline phosphatase levels above 3 x upper limit of normal (ULN) at visit 1.
- Renal impairment, defined as eGFR \<20 mL / min / 1.73 m2 or dialysis requirement, as determined at Visit 1.
- History of ketoacidosis
- Gastrointestinal surgery or gastrointestinal disturbance that could impair drug absorption
- Presence of any disease with a life expectancy \<1 year in the opinion of the investigator.
- Treatment with any SGLT-2 inhibitor for up to 3 months prior to study enrollment.
- Pregnancy or breastfeeding
- Drug or alcohol abuse
- Suspected non-compliance and irregular use of study drug
- Inability to perform CMR, e.g. claustrophobia, weight\> 120 kg, etc.
Key Trial Info
Start Date :
September 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT05271162
Start Date
September 30 2023
End Date
February 1 2028
Last Update
November 21 2025
Active Locations (2)
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1
Institute of Hematology and Transfusion Medicine
Warsaw, Poland
2
National Institute of Oncology
Warsaw, Poland