Phase 3 Heart Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are older than 18 and younger than 80 years of age.
- People who have been diagnosed with invasive breast cancer (stage I, II, or III) and who are planned to start a type of chemotherapy called anthracycline within 60 days.
- People who have signed a consent form agreeing to take part in the study.
Who may not be able to join:
- People who have a urinary tract infection requiring antibiotic treatment within 48 hours before the planned start of chemotherapy.
- People who have been diagnosed with heart failure, or who have symptoms that the trial doctor thinks could be signs of undiagnosed heart failure.
- People whose heart pumping strength (left ventricular ejection fraction) is below 50% at the time of screening.
- People who have a serious heart valve condition.
- People with a history of a significant abnormal heart rhythm, including atrial fibrillation of any type (at the trial doctor's judgment).
- People who have had a stroke.
- People who have any form of cardiomyopathy, which is a disease affecting the heart muscle (including inherited, post-inflammatory, toxic, or other specific types).
- People who have high blood pressure in the lungs (pulmonary hypertension).
- People with blood pressure that is not well controlled, or whose systolic blood pressure is below 80 mmHg at screening (at the trial doctor's judgment).
- People with a body mass index (BMI) above 40.
- People who have been diagnosed with type 1 or type 2 diabetes, or whose blood sugar levels at screening are above certain thresholds (confirm with trial site).
- People who are pregnant or breastfeeding.
- People who are not willing or able to use a highly effective form of contraception during the trial.
- People who are expected to receive specific types of chemotherapy drugs (epirubicin or liposomal doxorubicin) within 12 months.
- People who have taken another study drug, or a medication from a group called SGLT2 inhibitors, in the 6 months before the screening visit.
- People who have taken the medications semaglutide, liraglutide, or metformin in the 30 days before the screening visit.
- People whose kidneys are not filtering blood well enough, based on a specific kidney function test result (confirm with trial site).
- People whose cancer has spread to other parts of the body (stage IV), or whose life expectancy is less than 12 months.
- People whose liver enzyme levels (ALT or AST) are more than 2.5 times above the normal range.
- People who have anaemia with a haemoglobin level below 9 g/dl (a measure of low red blood cells).
- People with moderate to severe kidney failure (above a certain level on a standard kidney classification scale — confirm with trial site).
- People with liver problems above a certain level of severity (confirm with trial site).
- People with known, active infections including HIV, hepatitis B, hepatitis C, or tuberculosis.
- People with any other condition that, in the trial doctor's opinion, would make it impossible to safely participate in the study.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Waldemar Banasiak, PhD, MD, 4th Military Clinical Hospital with Polyclinic
Phone: +48 261 660 234
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.