Status:
COMPLETED
Dapagliflozin to Prevent Anthracycline-Induced Cardiotoxicity
Lead Sponsor:
Hawler Medical University
Collaborating Sponsors:
University of Zakho
Conditions:
Anthracyclines-Induced Cardiotoxicity
Cardiotoxicity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Brief Summary Anthracyclines (e.g., doxorubicin) are effective anticancer agents but can cause dose-dependent, often irreversible cardiotoxicity via oxidative stress, mitochondrial dysfunction, and ca...
Detailed Description
Background and Rationale Chemotherapy-induced cardiotoxicity is a significant concern in cancer treatment, particularly with anthracyclines (e.g., doxorubicin). Anthracycline-induced cardiotoxicity is...
Eligibility Criteria
Inclusion
- Histologically confirmed breast cancer (or other cancers as relevant to the study).
- Age 18-70 years.
- Planned treatment with anthracycline-based chemotherapy
- Normal kidney function, defined as serum creatinine 0.6-1.2 mg/dL.
- Normal liver function, defined as ALT and AST 10-40 U/L.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Willingness to participate and provide written informed consent.
Exclusion
- History of symptomatic heart failure (NYHA class III-IV) or prior anthracycline-related cardiac dysfunction.
- Previous use of Dapagliflozin.
- Pregnancy or breastfeeding.
- Severe renal impairment (eGFR \< 30 mL/min/1.73m²).
- Uncontrolled diabetes mellitus (HbA1c \> 9%).
- Active or recurrent urinary tract infections (UTIs) within the last 6 months.
- Known hypersensitivity to Dapagliflozin or related compounds.
- Concurrent participation in another clinical trial investigating cardioprotective agents.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 6 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT06888505
Start Date
September 1 2024
End Date
September 6 2025
Last Update
September 18 2025
Active Locations (1)
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1
Azadi Oncology Centre
Duhok, Iraq, 42001