Actively Recruiting
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines
Led by Maria Sklodowska-Curie National Research Institute of Oncology · Updated on 2025-11-21
220
Participants Needed
2
Research Sites
226 weeks
Total Duration
On this page
Sponsors
M
Maria Sklodowska-Curie National Research Institute of Oncology
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
EMPACT (EMPAgliflozin in prevention of chemotherapy-related CardioToxicity) study is a randomized, multi-center, placebo-controlled, double-blind trial to evaluate efficacy of empagliflozin in prevention of left ventricular (LV) dysfunction in patients receiving high cumulative doses of anthracyclines. Diagnosed with cancer, 220 patients without history of heart failure and LV ejection fraction (EF) ≥ 50%, scheduled for high dose anthracyclines (doxorubicin ≥240 mg/m2 or epirubicin ≥540 mg/m2), will be included in the study. They will be randomized to a 10 mg of empagliflozin once daily or to matching placebo in a 1:1 ratio. The primary objective of the EMPACT study is to assess whether prophylactic SGLT-2 inhibitors may prevent a reduction in LVEF after high doses anthracyclines, as evaluated by serial echocardiography on each visit and cardiovascular magnetic resonance (CMR) performed at randomization and on its completion. The secondary composite endpoint includes: all-cause death, cardiovascular (CV) death, myocardial infarction and ischemic stroke. Additional secondary outcome measures include structural myocardial alterations assessed by CMR, decrease in GLS (global longitudinal strain) in echocardiography and changes in cardiac biomarkers. The study will be carried out in accordance with GCP and monitoring will be outsourced to a subcontractor - CRO. The examination will be insured and will begin as soon as the required approvals are obtained.
CONDITIONS
Official Title
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with cancer and qualified for further systemic treatment at the National Institute of Oncology in Warsaw
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Age 18 years or older at the time of signing informed consent
- Planned chemotherapy with high-dose anthracyclines (doxorubicin ≥ 240 mg/m2 or epirubicin ≥ 540 mg/m2)
- No history of heart failure and left ventricular ejection fraction ≥ 50% by echocardiography
- Women of childbearing age must have a negative pregnancy test
- All participants must agree to use effective contraception during the study and after stopping the study drug
- Sexually active women must use two effective contraception methods from consent and for at least 6 months after stopping the drug
- Sexually active men and partners must use effective contraception from consent and for at least 3 months after stopping the drug
You will not qualify if you...
- History of heart failure
- Left ventricular ejection fraction less than 50%
- Significant valve disease
- Previous chemotherapy or radiation to the chest
- Symptomatic low blood pressure or systolic blood pressure below 100 mmHg at visits 1 or 2
- Liver disease with elevated liver enzymes above 3 times the upper limit of normal at visit 1
- Severe kidney impairment (eGFR below 20 mL/min/1.73 m2) or dialysis requirement
- History of ketoacidosis
- Gastrointestinal surgery or disorders affecting drug absorption
- Any disease with life expectancy less than one year
- Treatment with any SGLT-2 inhibitor within 3 months before enrollment
- Pregnancy or breastfeeding
- Drug or alcohol abuse
- Suspected poor compliance or irregular use of study drug
- Inability to undergo cardiovascular magnetic resonance imaging due to claustrophobia, weight over 120 kg, or other reasons
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Institute of Hematology and Transfusion Medicine
Warsaw, Poland
Not Yet Recruiting
2
National Institute of Oncology
Warsaw, Poland
Actively Recruiting
Research Team
A
Anna Borowiec, Ph D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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