Cardioprotection Effect of Linagliptin

Condition(s) studied

Investigational drug(s) / intervention(s)

Doxorubicin: Standard oncologic care without cardioprotective intervention followed concurrently for 24 weeks

Empaglifloz 5 mg orally once daily: Initiated 1 week prior to chemotherapy; continued for 24 weeks

Study summary

1\. Background and Rationale Breast cancer is one of the most common malignancies affecting women worldwide and represents a major health burden in Egypt. Anthracyclines, particularly doxorubicin, remain an important component of several breast cancer chemotherapy regimens. However, their clinical utility is limited by the potential development of anthracycline-induced cardiotoxicity.

Doxorubicin-induced cardiac injury is multifactorial and involves oxidative stress, mitochondrial dysfunction, disturbances in myocardial energy metabolism, apoptosis, inflammation, and progressive myocardial structural damage. Cardiac injury may initially occur without symptoms or an obvious reduction in left ventricular ejection fraction (LVEF). Consequently, identification of early myocardial injury is important because intervention before clinically apparent heart failure may potentially reduce progression to overt cardiac dysfunction.

Eligibility

Primary outcome measure(s)

• Cardiac Troponin Assessment — 3 months
  The principal biochemical endpoint will be defined as: Cardiac troponin concentration \>99th percentile upper reference limit of the laboratory assay. Acute myocardial injury will be characterized by a dynamic rise and/or fall in troponin when clinically appropriate.

Trial sites (1)

More Tanta University trials in Egypt

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