A Phase 3, Randomized, Double-blind, Placebo-controlled Study to evaluate Efficacy and Safety of Empagliflozin in the prevention of Cardiotoxicity in Cancer patients undergoing Chemotherapy based on Anthracyclines (EMPACT study)
- Conditions
- Cardiotoxicity. The study population will consist of patients diagnosed with cancer, without history of heart failure and LV ejection fraction (EF) = 50%, scheduled for high dose anthracyclines (doxorubicin =240 mg/m2 or epirubicin =360 mg/m2) as standard of care (SoC) systemic anticancer treatment.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-515495-13-00
- Lead Sponsor
- arodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2., = 18 years of age 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 = 360 mg / m2 b.w.), No history of heart failure (left ventricular ejection fraction = 50% as assessed by echocardiography)., Ability to give written informed consent and comply with protocol requirements., 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., Women of childbearing potential (WOCBP) must meet and/or agree to all the following for contraception: a. 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. b. agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same time period., 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.
History of heart failure., 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 enrolment., Pregnant or lactating females., Drug or alcohol abuse., Suspected non-compliance and irregular use of study drug., Inability to perform cardiac MRI due to, e.g., claustrophobia, weight> 120 kg., 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 Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method