NCT05271162: EMPACT

Empagliflozin in the Prevention of Cardiotoxicity in Cancer Patients Undergoing Chemotherapy Based on Anthracyclines

Recruiting now Phase 3 Last updated 21 November 2025

What this trial tests

Phase 3 trial testing Empagliflozin 10 MG in Cardiotoxicity in 220 participants. Currently enrolling.

Timeline

30 September 2023

Primary endpoint
1 January 2028

1 February 2028

Quick facts

Lead sponsor	Maria Sklodowska-Curie National Research Institute of Oncology
Phase	Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	220
Start date	30 September 2023
Primary completion	1 January 2028
Estimated completion	1 February 2028
Sites	2 locations across Poland

Drugs / interventions tested

• Empagliflozin 10 MG — full drug profile →
• Placebo

Conditions studied

• Cardiotoxicity — all drugs for Cardiotoxicity →

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Who can join

18 and older, any sex, with Cardiotoxicity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. SGLT2 inhibitors: from glucose-lowering to cardiovascular benefits.
   Preda A, Montecucco F, Carbone F, Carbone F, et al · · 2024 · cited 76× · PMID 38456601 · DOI 10.1093/cvr/cvae047
2. The Cardioprotective and Anticancer Effects of SGLT2 Inhibitors: <i>JACC: CardioOncology</i> State-of-the-Art Review.
   Dabour MS, George MY, Daniel MR, Blaes AH, et al · · 2024 · cited 68× · PMID 38774006 · DOI 10.1016/j.jaccao.2024.01.007
3. The Association of Sodium-Glucose Cotransporter 2 Inhibitors With Cardiovascular Outcomes in Anthracycline-Treated Patients With Cancer.
   Abdel-Qadir H, Carrasco R, Austin PC, Chen Y, et al · · 2023 · cited 61× · PMID 37397088 · DOI 10.1016/j.jaccao.2023.03.011
4. Cardioprotection strategies for anthracycline cardiotoxicity.
   Moreno-Arciniegas A, Cádiz L, Galán-Arriola C, Clemente-Moragón A, et al · · 2025 · cited 16× · PMID 39249555 · DOI 10.1007/s00395-024-01078-6
5. SGLT2 Inhibitors in Cancer Patients: A Comprehensive Review of Clinical, Biochemical, and Therapeutic Implications in Cardio-Oncology.
   Greco A, Canale ML, Quagliariello V, Oliva S, et al · · 2025 · cited 14× · PMID 40429921 · DOI 10.3390/ijms26104780
6. Effects of sodium-glucose cotransporter 2 inhibitors in patients with cancer and diabetes mellitus: a systematic review and meta-analysis.
   Novo G, Madaudo C, Cannatà A, Ameri P, et al · · 2025 · cited 12× · PMID 40274419 · DOI 10.1093/ehjcvp/pvaf028
7. SGLT2i Therapy Prevents Anthracycline-Induced Cardiotoxicity in a Large Animal Model by Preserving Myocardial Energetics.
   Medina-Hernández D, Cádiz L, Mastrangelo A, Moreno-Arciniegas A, et al · · 2025 · cited 9× · PMID 39967204 · DOI 10.1016/j.jaccao.2024.12.004
8. Sodium-Glucose Cotransporter 2 Inhibitors During Cancer Therapy: Benefits, Risks, and Ongoing Clinical Trials.
   Osataphan N, Abdel-Qadir H, Zebrowska AM, Borowiec A. · · 2024 · cited 9× · PMID 38990501 · DOI 10.1007/s11912-024-01577-8