Tanta University
Tanta, El Gharbia, 31111, Egypt
NCT Number: NCT07370506
This study aims to evaluate the efficacy and safety of telmisartan as a cardioprotective agent in patients receiving doxorubicin-based chemotherapy, with the goal of reducing treatment-associated cardiotoxicity, optimizing therapeutic outcomes, and facilitating the safer administration of anthracycline regimens.
Trial opening soon.
Get Notified18 year–65 year
Female
Interventional
Phase 1 / Phase 2
Tanta, El Gharbia, 31111, Egypt
Doxorubicin remains one of the most effective chemotherapeutic agents for the treatment of a wide range of solid tumors and hematological malignancies. However, its clinical use is limited by dose-dependent cardiotoxicity, which may manifest as subclinical myocardial injury, left ventricular dysfunction, and progression to heart failure. The mechanisms underlying doxorubicin-induced cardiotoxicity are multifactorial, with oxidative stress recognized as a central pathway contributing to reactive oxygen species (ROS) generation, mitochondrial dysfunction, and cardiomyocyte injury. These effects highlight the need for strategies to reduce cardiovascular complications associated with doxorubicin therapy without compromising anticancer efficacy.
Telmisartan, an angiotensin II type 1 receptor blocker (ARB), has demonstrated pharmacological effects beyond blood pressure control. Preclinical studies suggest that telmisartan may reduce oxidative stress, improve endothelial function, and preserve mitochondrial integrity, partly through modulation of peroxisome proliferator-activated receptor gamma (PPAR-γ) pathways. These effects may contribute to attenuation of cardiac remodeling and myocardial injury. Despite these observations, clinical evidence evaluating telmisartan for the prevention of doxorubicin-induced cardiotoxicity remains limited and inconclusive. Recent in vitro findings also indicate that telmisartan may enhance doxorubicin-induced apoptosis and cytotoxic efficacy in cancer cell lines. These findings raise the possibility that telmisartan could exert both cardioprotective and chemosensitizing effects.
Considering this evidence gap, the present study is designed to investigate the cardioprotective role of telmisartan in patients undergoing doxorubicin-based chemotherapy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Telmisartan administered orally once daily as cardioprotective therapy during doxorubicin-based chemotherapy.
Standard doxorubicin-based chemotherapy according to institutional protocol.
Time frame: Baseline to end of chemotherapy (approximately 12-18 weeks)
The primary outcome is the absolute change in left ventricular ejection fraction (LVEF) from baseline to the end of doxorubicin-based chemotherapy, assessed by echocardiography.
Time frame: Baseline (pre-chemotherapy) to end of chemotherapy (approximately 12-18 weeks)
Measurement of serum hs-cTnT at baseline and at the end of doxorubicin-based chemotherapy to assess myocardial injury and cardiac stress in patients receiving telmisartan or standard care.
Time frame: Baseline to end of chemotherapy (approximately 12-18 weeks)
Measurement of serum NT-proBNP at baseline and at the end of doxorubicin-based chemotherapy. Any increase from baseline indicates early ventricular strain or subclinical heart failure in patients receiving telmisartan or standard care.
Contact information is provided by the study sponsor or research team.
Tanta University
Other
Efficacy of Telmisartan in Preventing Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients
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