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)

Korábbi kezelés

• Treatment with any SGLT-2 inhibitor for up to 3 months prior to study enrolment.
• Drug or alcohol abuse.
• Suspected non-compliance and irregular use of study drug.
• Previous chemotherapy or radiation to the chest.
• Gastrointestinal surgery or gastrointestinal disturbance that could impair drug absorption.

Más betegség

• History of heart failure.
• Presence of any disease with a life expectancy <1 year in the opinion of the Investigator.
• Inability to perform cardiac MRI due to, e.g., claustrophobia, weight> 120 kg.
• Significant valve disease
• History of ketoacidosis.

Laborértékek

• Left ventricle systolic dysfunction assessed by echocardiography (LVEF<50%).
• 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.

Egyéb

• Pregnant or lactating females.
• Symptomatic hypotension and / or SBP <100 mmHg at Visit 1 or Visit 2.

• 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.