Heart shield: diabetes drug may prevent Chemo-Induced cardiac damage
NCT ID NCT05271162
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether empagliflozin, a drug used for diabetes, can prevent heart damage in cancer patients receiving strong chemotherapy (anthracyclines). About 220 adults with cancer but no prior heart failure will take either the drug or a placebo daily for 12 months. The goal is to see if the drug helps maintain heart function and reduce serious heart-related events.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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220 people
The number who actually took part.
- Started
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Sep 2023
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Institute of Hematology and Transfusion Medicine
Warsaw, Poland
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National Institute of Oncology
Warsaw, Poland
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Other studies related to the condition(s) this trial covers.
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