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

NCT07370506 | Not Yet Recruiting Phase 1

• 1 other identifier: 2467R4
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer; Doxorubicin Induced Cardiomyopathy

Keywords

Telmisartan; Anthracycline Cardiotoxicity; Troponin; NT-proBNP; Cardioprotection

Outcome Measures

Primary Outcomes (1)

• Change in Left Ventricular Ejection Fraction (LVEF)

  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 Outcomes (2)

• Change in High-Sensitivity Cardiac Troponin T (hs-cTnT) Levels

  Baseline (pre-chemotherapy) to end of chemotherapy (approximately 12-18 weeks)

• Change in N-terminal pro-B-type Natriuretic Peptide (NT-proBNP) Levels

  Baseline to end of chemotherapy (approximately 12-18 weeks)

Study Arms (2)

Telmisartan Group

EXPERIMENTAL

Participants receiving telmisartan in addition to standard doxorubicin-based chemotherapy.

Drug: Telmisartan; Drug: Doxorubicin (DOX)

Control Group

ACTIVE COMPARATOR

Participants receiving standard doxorubicin-based chemotherapy without telmisartan.

Drug: Doxorubicin (DOX)

Interventions

Telmisartan DRUG

Telmisartan administered orally once daily as cardioprotective therapy during doxorubicin-based chemotherapy.

Telmisartan Group

Doxorubicin (DOX) DRUG

Standard doxorubicin-based chemotherapy according to institutional protocol.

Control Group; Telmisartan Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El Gharbia, 31111, Egypt

Location

Related Publications (5)

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  PMID: 16247224 BACKGROUND

• Taniguchi N. From the gamma-glutamyl cycle to the glycan cycle: a road with many turns and pleasant surprises. J Biol Chem. 2009 Dec 11;284(50):34469-78. doi: 10.1074/jbc.X109.023150. Epub 2009 Oct 19. No abstract available.

  PMID: 19840938 BACKGROUND

• Arciuli J, Simpson IC. Statistical learning is lasting and consistent over time. Neurosci Lett. 2012 May 31;517(2):133-5. doi: 10.1016/j.neulet.2012.04.045. Epub 2012 Apr 25.

  PMID: 22561650 BACKGROUND

• Simeunovic B, Strbenc M, Bavdek SV. Position and histological structure of the testes in the brown hare (Lepus europaeus) during seasonal regression and recrudescence. Anat Histol Embryol. 2000 Apr;29(2):73-82. doi: 10.1046/j.1439-0264.2000.00233.x.

  PMID: 10932383 BACKGROUND

• Banegas JR, Segura J, Ruilope LM, Luque M, Garcia-Robles R, Campo C, Rodriguez-Artalejo F, Tamargo J; CLUE Study Group Investigators. Blood pressure control and physician management of hypertension in hospital hypertension units in Spain. Hypertension. 2004 Jun;43(6):1338-44. doi: 10.1161/01.HYP.0000127424.59774.84. Epub 2004 Apr 26.

  PMID: 15117908 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Telmisartan; Doxorubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Central Study Contacts

Menna Ahmed

CONTACT

+20 1000854864; mennagalal822@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant (Demonstrator) of Clinical Pharmacy

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)