Heart shield: diabetes drug may prevent Chemo-Induced cardiac damage

NCT ID NCT05271162

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

220 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

cancer Cardiotoxicity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Institute of Hematology and Transfusion Medicine

    Warsaw, Poland

  • National Institute of Oncology

    Warsaw, Poland

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