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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)
EU CTIS ID: 2024-515495-13-00
What this study is testing
The primary objective is to evaluate the efficacy of empagliflozin 10 mg versus placebo in prevention of left ventricular (LV) dysfunction in cancer patients receiving high cumulative doses of anthracyclines
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.