Using empagliflozin to prevent heart damage in cancer patients receiving chemotherapy
Evaluation of the Effectiveness of Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines (EMPACT Study).
This study is testing if the medication empagliflozin can help prevent heart damage in cancer patients receiving chemotherapy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 220 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Maria Sklodowska-Curie National Research Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation, doxorubicin |
| Locations | 2 sites (Warsaw and 1 other locations) |
| Trial ID | NCT05271162 on ClinicalTrials.gov |
What this trial studies
The EMPACT study is a randomized, multi-center, placebo-controlled, double-blind trial aimed at evaluating the efficacy of empagliflozin in preventing left ventricular dysfunction in cancer patients undergoing high doses of anthracycline chemotherapy. A total of 220 patients without a history of heart failure and with a left ventricular ejection fraction of 50% or greater will be enrolled. Participants will be randomly assigned to receive either 10 mg of empagliflozin daily or a matching placebo. The primary objective is to assess whether empagliflozin can prevent a reduction in left ventricular ejection fraction, monitored through serial echocardiography and cardiovascular magnetic resonance imaging. Secondary endpoints include all-cause mortality and other cardiovascular outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosed cancer who are scheduled to receive high doses of anthracyclines and have no history of heart failure.
Not a fit: Patients with a history of heart failure or those not receiving anthracycline chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of heart damage in cancer patients undergoing chemotherapy, improving their overall health outcomes.
How similar studies have performed: While the use of SGLT-2 inhibitors for cardioprotection is a novel approach in this context, similar studies have shown promising results in other cardiovascular conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
The study will include patients with diagnosed cancer, diagnosed and qualified for further systemic treatment at the National Institute of Oncology in Warsaw. Patients must give informed and voluntary consent to participate in the study and meet all the conditions for inclusion in the study Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2. 2. Age ≥18 years at the time of signing the informed consent. 3. Known neoplastic disease prior to the initiation of chemotherapy with a high dose of anthracyclines (doxorubicin ≥ 240 mg / m2 b.w. or epirubicin ≥ 540 mg / m2 b.w.) 4. No history of heart failure (left ventricular ejection fraction ≥ 50% as assessed by echocardiography). 5. Women of child-bearing age must have a negative serum or urine pregnancy test. 6. All males and females must consent to the use of effective contraception throughout the study period and after study medication is discontinued. 7. Sexually active women of childbearing potential must use 2 effective methods of contraception (abstinence, IUD, oral contraceptive or double barrier device) from informed consent and for at least 6 months after study drug discontinuation 8. Sexually active men and their sexual partners must use effective methods of contraception from the moment they sign their informed consent to participate in the study and for at least 3 months after discontinuation of the study drug. Exclusion Criteria: 1. History of heart failure 2. Left ventricle systolic dysfunction assessed by echocardiography (LVEF \<50%) 3. Significant valve disease 4. Previous chemotherapy or radiation to the chest 5. Symptomatic hypotension and / or SBP \<100 mmHg at Visit 1 or Visit 2 6. Liver disease, as determined by ALT, AST, or alkaline phosphatase levels above 3 x upper limit of normal (ULN) at visit 1. 7. Renal impairment, defined as eGFR \<20 mL / min / 1.73 m2 or dialysis requirement, as determined at Visit 1. 8. History of ketoacidosis 9. Gastrointestinal surgery or gastrointestinal disturbance that could impair drug absorption 10. Presence of any disease with a life expectancy \<1 year in the opinion of the investigator. 11. Treatment with any SGLT-2 inhibitor for up to 3 months prior to study enrollment. 12. Pregnancy or breastfeeding 13. Drug or alcohol abuse 14. Suspected non-compliance and irregular use of study drug 15. Inability to perform CMR, e.g. claustrophobia, weight\> 120 kg, etc.
Where this trial is running
Warsaw and 1 other locations
- Institute of Hematology and Transfusion Medicine — Warsaw, Poland (Not_yet_recruiting)
- National Institute of Oncology — Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Anna Borowiec, PhD — Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, POLAND
- Study coordinator: Anna Borowiec, Ph D
- Email: anna.borowiec@pib-nio.pl
- Phone: +48225463289
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.