Cardioprotective Empagliflozin for Cancer Patients Receiving Doxorubicin

Launched by AIN SHAMS UNIVERSITY · Oct 22, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Empagliflozin to see if it can help protect the heart in cancer patients who are receiving a type of chemotherapy called doxorubicin. Doxorubicin can sometimes cause serious heart problems, and researchers want to find out if Empagliflozin can reduce these heart-related side effects. The trial will focus on patients who are starting their first round of treatment with doxorubicin and who have no prior heart issues.

To participate in this study, patients need to be between the ages of 18 and 75, be newly diagnosed with cancer, and plan to receive at least four cycles of doxorubicin. They should also have normal heart function and no significant previous heart conditions. Participants will receive Empagliflozin along with their chemotherapy and will be monitored for any effects on their heart health and overall safety. This trial is not yet recruiting, but it's an important step in understanding how to better protect the hearts of cancer patients undergoing treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Chemo-naive patients with a first diagnosis of cancer and indication for first-line therapy with doxorubicin-based chemotherapy.
• • 2. Patients intended to receive at least 4 cycles of doxorubicin or greater.
• • 3. No previous cardiac conditions (including ischemic heart disease and clinically important congenital or acquired valvular and myocardial diseases) and taking no cardiac-related drugs.
• • 4. An echocardiographic LVEF value ≥55%.
• • 5. Normal hepatic and renal function (bilirubin ≤1.5 mg/dL, creatinine ≤2.0 mg/dL).
• • 6. ECOG performance grade 0, 1 or 2.
• Exclusion Criteria:
• • 1. Hypersensitivity / Allergy to Empagliflozin.
• • 2. Any condition that contraindicates chemotherapy (i.e., pregnancy, lactation).
• • 3. New-onset cardiac symptoms or presence of congestive heart failure symptoms or established (dilated, restrictive or hypertrophic) cardiomyopathy, coronary heart disease, moderate or severe aortic and/or mitral valve disease or atrial fibrillation detected by baseline echocardiography.
• • 4. Systemic hypertension, acute coronary syndrome or cardiac surgery within the last 3 months.
• • 5. Patients with known history or current treatment with cardiotoxic agents.
• • 6. Receiving radiation on the left side of body.
• • 7. History of rheumatic fever
• • 8. Alcohol abuse.
• • 9. Current participation in any other clinical investigation.
• • 10. End-stage renal disease or patients on dialysis.
• • 11. Patients with diabetic ketoacidosis or patients with type 1 diabetes mellitus.
• • 12. Glomerular Filtration Rate \<30ml/Kg/min.