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

NCT05271162 | Recruiting Phase 3 DMC

• 1 other identifier: ABM/03/00012
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cardiotoxicity

Keywords

Cardiotoxicity; Empagliflozin; Anthracyclines

Outcome Measures

Primary Outcomes (1)

• Number of participants with diagnosis of cancer treatment-related cardiac dysfunction (CTRCD) at any time over the 12-month study period

  CTRCD is defined as decrease in LVEF in echocardiography of at least 10% from baseline to a final LVEF of less than 50% and/or a relative decrease of at least 15% in global longitudinal strain (GLS) from baseline.

  from date of randomization until 12 months

Secondary Outcomes (7)

• Rate of episodes of all-cause death, cardiovascular death, myocardial infarction, and stroke

  from date of randomization up to 12 months

• Percentage decrease in left ventricular ejection fraction, GLS (global longitudinal strain)

  from date of randomization up to 12 months

• Rate of structural myocardial alterations in CMR

  from date of randomization up to 12 months

• Changes in the concentration of biomarkers

  from date of randomization up to 12 months

• The difference in scores in the KCCQ (Kansas City Cardiomyopathy Questionnaire) assessing the quality of life of patients.

  from date of randomization up to 12 months

Study Arms (2)

Empagliflozin

ACTIVE COMPARATOR

Empagliflozin, 10 mg q.d; p.o

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Placebo 1 tabl q.d; p.o

Other: Placebo

Interventions

Empagliflozin 10 MG DRUG

Empagliflozin 10 mg q.d; p.o

Also known as: Jardiance

Empagliflozin

Placebo OTHER

Placebo 1 tabl q.d; p.o

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• History of ketoacidosis
• Gastrointestinal surgery or gastrointestinal disturbance that could impair drug absorption
• Presence of any disease with a life expectancy \<1 year in the opinion of the investigator.
• Treatment with any SGLT-2 inhibitor for up to 3 months prior to study enrollment.
• Pregnancy or breastfeeding
• Drug or alcohol abuse
• Suspected non-compliance and irregular use of study drug
• Inability to perform CMR, e.g. claustrophobia, weight\> 120 kg, etc.

Sponsors & Collaborators

• Maria Sklodowska-Curie National Research Institute of Oncology: lead
• Medical Research Agency, Poland: collaborator

Study Sites (2)

Institute of Hematology and Transfusion Medicine

Warsaw, Poland

NOT YET RECRUITING

National Institute of Oncology

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Anna Borowiec, PhD

  Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, POLAND

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Borowiec, Ph D

CONTACT

+48225463289; anna.borowiec@pib-nio.pl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 20, 2022
• First Posted: March 8, 2022
• Study Start: September 30, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: In September For 6 years

Locations

PL (2)