Cardioprotection Effect of Linagliptin

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18+
SponsorTanta University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

1. Female patients aged ≥18 years. 2. Egyptian nationality. 3. Histologically confirmed breast cancer. 4. Planned treatment with a doxorubicin-containing chemotherapy regimen. 5. Expected cumulative doxorubicin dose of approximately ≥240 mg/m², or another prespecified protocol threshold.

Disqualifiers

1. Previous exposure to anthracyclines. 2. Known heart failure. 3. Baseline LVEF <53%. 4. Previous myocardial infarction or significant coronary artery disease. 5. Significant valvular heart disease. 6. Clinically significant arrhythmia. 7. Uncontrolled hypertension. 8. Significant renal impairment according to a predefined eGFR threshold. 9. Significant hepatic impairment. 10. Active infection or another condition likely to affect troponin interpretation.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Doxorubicin

    Drug

    Standard oncologic care without cardioprotective intervention followed concurrently for 24 weeks

  • Empaglifloz 5 mg orally once daily

    Drug

    Initiated 1 week prior to chemotherapy; continued for 24 weeks

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Arm A (Control)Placebo comparator 1 intervention
Group B: Arm B (Linagliptin)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Cardiac Troponin Assessment

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.

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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