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Heart shield? diabetes drug tested to prevent chemo heart damage

NCT ID NCT07245069

Prevention Sponsor: University Medical Centre Ljubljana Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether dapagliflozin, a drug used for diabetes and heart failure, can prevent heart damage caused by a common type of chemotherapy (anthracyclines) in breast cancer patients. One hundred women will receive either dapagliflozin or a placebo daily during their chemotherapy. Researchers will monitor heart function and blood markers to see if the drug offers protection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin
What this could lead to
If it works, this could point toward a way to protect the heart during breast cancer chemotherapy, reducing the risk of long-term heart problems.
What could go wrong
This is a small, early-stage (Phase 2) study, so results may not be definitive. Dapagliflozin may not prevent heart damage, and it can have side effects like dehydration or urinary infections.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2029

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.

Inclusion Criteria: * Adults ≥18 years. * Histologically confirmed breast cancer with planned (neo)adjuvant anthracycline-based chemotherapy (4 cycles of epirubicin + cyclophosphamide or doxorubicin + cyclophosphamide). * Eligible to start dapagliflozin or placebo prior to or at initiation of chemotherapy. * Able to perform baseline echocardiography, vascular ultrasound (FMD and carotid stiffness), 6-minute walk test, and biomarker sampling. * Willing and able to provide written informed consent. Exclusion Criteria: * Known heart failure (any prior diagnosis of HF). * Clinically significant valvular heart disease. * Prior exposure to chemotherapy or radiotherapy to the left chest. * Type 1 diabetes mellitus. * Symptomatic hypotension. * History of recurrent urinary tract infections. * History of diabetic ketoacidosis or ketonemia. * Severe hepatic impairment (ALT, AST, ALP \>3× upper limit of normal). * Severe renal impairment (eGFR \<20 mL/min/1.73 m²). * Known allergy or intolerance to SGLT-2 inhibitors. * Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment. * Pregnancy or breastfeeding. * Any condition that, in the investigator's judgment, could interfere with study participation, safety, or completion.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm heart failure Inflammation cardiomyopathy due to anthracyclines prevention target

As listed by the trial registrant

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

Anthracycline-induced cardiac toxicity Arterial stiffness Breast cancer Endothelial function (FMD) Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Medical Centre Ljubljana

    RECRUITING

    Ljubljana, 1000, Slovenia

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