Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Base… (NCT05271162) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines
Poland220 participantsStarted 2023-09-30
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
. Age ≥18 years at the time of signing the informed consent.
. 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.)
. No history of heart failure (left ventricular ejection fraction ≥ 50% as assessed by echocardiography).
. Women of child-bearing age must have a negative serum or urine pregnancy test.
. All males and females must consent to the use of effective contraception throughout the study period and after study medication is discontinued.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with diagnosis of cancer treatment-related cardiac dysfunction (CTRCD) at any time over the 12-month study period
Timeframe: from date of randomization until 12 months
Trial details
NCT IDNCT05271162
SponsorMaria Sklodowska-Curie National Research Institute of Oncology
. 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
. 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
. History of heart failure
. Left ventricle systolic dysfunction assessed by echocardiography (LVEF \<50%)
. Significant valve disease
. Previous chemotherapy or radiation to the chest
. Symptomatic hypotension and / or SBP \<100 mmHg at Visit 1 or Visit 2
. Liver disease, as determined by ALT, AST, or alkaline phosphatase levels above 3 x upper limit of normal (ULN) at visit 1.
. Renal impairment, defined as eGFR \<20 mL / min / 1.73 m2 or dialysis requirement, as determined at Visit 1.