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

Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Study ID
NCT05271162
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Cardiotoxicity

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Empagliflozin 10 MG — DRUG
    Empagliflozin 10 mg q.d; p.o
  • Placebo — OTHER
    Placebo 1 tabl q.d; p.o

Study Details

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.

Key Dates

Start date
Sep 30, 2023
Status verified
Jun 2026
Primary completion
Jan 1, 2028
Completion
Feb 24, 2028

Study Design

Enrollment
220 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Empagliflozin
    Empagliflozin, 10 mg q.d; p.o
  • Placebo Comparator: Placebo
    Placebo 1 tabl q.d; p.o

Primary Outcome Measure

Number of participants with diagnosis of cancer treatment-related cardiac dysfunction (CTRCD) at any time over the 12-month study period [ Time Frame: from date of randomization until 12 months ]

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