Phase 3 Heart Disease Trial, Recruiting NCT06304857 Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland Condition: Heart Disease
Back to Heart Disease

Phase 3 Heart Disease Trial, Recruiting

NCT06304857
Recruiting Phase 3

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 13 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 3
Sponsor
4th Military Clinical Hospital with Polyclinic, Poland
Registry
ClinicalTrials.gov
Start date
15 April 2024
Est. completion
31 December 2026

Where this trial is recruiting

🇵🇱 Poland

Primary endpoints

Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov