Telmisartan for Prevention of Doxorubicin-Induced Cardiotoxicity in Breast Cancer Patients

January 27, 2026 updated by: Mennatullah Galal Ahmed Barakat, Tanta University

Efficacy of Telmisartan in Preventing Doxorubicin-induced Cardiotoxicity in Breast Cancer Patients

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • El Gharbia
      • Tanta, El Gharbia, Egypt, 31111
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female patients with breast cancer.
  • Age ≥18 & ≤ 65 years.
  • Newly diagnosed, chemotherapy-naïve patients.
  • Baseline echocardiogram showing left ventricular ejection fraction (LVEF) ≥55%.

Exclusion Criteria:

  • Presence of hypersensitivity to telmisartan.
  • History of cardiovascular disease (e.g., congestive heart failure, ischemic heart disease, arrhythmia).
  • Patients with any chronic liver or renal dysfunction; inflammatory diseases; autoimmune disease; acute cardiovascular events, eating disorders (anorexia, bulimia) or gastrointestinal disorders.
  • Baseline blood pressure ≥ 160/100 mmHg
  • Current or prior use of ARBs/ACE inhibitors
  • Current participation in another clinical trial within the past 30 days.
  • Pregnant or breastfeeding women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telmisartan Group
Participants receiving telmisartan in addition to standard doxorubicin-based chemotherapy.
Drug: Telmisartan
Telmisartan administered orally once daily as cardioprotective therapy during doxorubicin-based chemotherapy.
Drug: Doxorubicin (DOX)
Standard doxorubicin-based chemotherapy according to institutional protocol.
Active Comparator: Control Group
Participants receiving standard doxorubicin-based chemotherapy without telmisartan.
Drug: Doxorubicin (DOX)
Standard doxorubicin-based chemotherapy according to institutional protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Left Ventricular Ejection Fraction (LVEF)
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.
Baseline to end of chemotherapy (approximately 12-18 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in High-Sensitivity Cardiac Troponin T (hs-cTnT) Levels
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.
Baseline (pre-chemotherapy) to end of chemotherapy (approximately 12-18 weeks)
Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Levels
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.
Baseline to end of chemotherapy (approximately 12-18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2467R4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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