Dapagliflozin to Prevent Anthracycline-Induced Cardiotoxicity (NCT06888505) | Clinical Trial Compass
CompletedPhase 2
Dapagliflozin to Prevent Anthracycline-Induced Cardiotoxicity
Iraq94 participantsStarted 2024-09-01
Plain-language summary
Anthracyclines, such as doxorubicin, are effective anticancer agents but may cause dose-dependent cardiac injury, including early changes in left ventricular function and cardiac biomarkers. Dapagliflozin is a sodium-glucose cotransporter-2 inhibitor with established cardiovascular benefits in heart failure and potential cardioprotective effects beyond glucose lowering, including modulation of oxidative stress, inflammation, myocardial energetics and fibrotic remodeling.
This randomized, double-blind, placebo-controlled phase 2 trial evaluated whether dapagliflozin attenuates early anthracycline-associated cardiac functional and biomarker changes in adults receiving anthracycline-based chemotherapy. A total of 94 participants were randomized in a 1:1 ratio to receive dapagliflozin 10 mg orally once daily plus standard anthracycline-based chemotherapy or matching placebo plus standard anthracycline-based chemotherapy for 4 months. Ninety participants completed the 4-month follow-up and were included in complete-case analyses.
The primary echocardiographic outcome was change in left ventricular function from baseline to 4 months. Left ventricular systolic function was assessed using left ventricular ejection fraction (LVEF) as the principal systolic measure. Transmitral E/A ratio was analyzed as an exploratory filling index because it was consistently available across participants. Tissue Doppler indices and comprehensive diastolic dysfunction grading were not consistently available and were therefore not used for formal diastolic grading in the final analysis.
Secondary outcomes included cardiac troponin I, NT-proBNP, galectin-3, CA 15-3, renal and hepatic function parameters, and adverse events. Echocardiography and laboratory biomarkers were assessed at baseline and 4 months, while adverse events were monitored continuously throughout the study period.
Who can participate
Age range
18 Years – 70 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:
* Histologically confirmed breast cancer (or other cancers as relevant to the study).
* Age 18-70 years.
* Planned treatment with anthracycline-based chemotherapy
* Normal kidney function, defined as serum creatinine 0.6-1.2 mg/dL.
* Normal liver function, defined as ALT and AST 10-40 U/L.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Willingness to participate and provide written informed consent.
Exclusion Criteria:
* History of symptomatic heart failure (NYHA class III-IV) or prior anthracycline-related cardiac dysfunction.
* Previous use of Dapagliflozin.
* Pregnancy or breastfeeding.
* Severe renal impairment (eGFR \< 30 mL/min/1.73m²).
* Uncontrolled diabetes mellitus (HbA1c \> 9%).
* Active or recurrent urinary tract infections (UTIs) within the last 6 months.
* Known hypersensitivity to Dapagliflozin or related compounds.
* Concurrent participation in another clinical trial investigating cardioprotective agents.
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.
1This trial tested dapagliflozin — a diabetes drug — to protect the heart during anthracycline chemotherapy; can you walk me through what the echocardiogram results showed, and whether the heart function data looks promising enough to be relevant to my situation?
2Since this was a Phase 2 trial that has now completed, how confident can we be in the safety and effectiveness findings, and is there a larger Phase 3 study I should know about before making any decisions?
3Anthracycline-induced cardiotoxicity is a serious concern — how would you normally monitor my heart function during my chemotherapy, and does anything from this trial change how you'd approach that for me?
4Dapagliflozin is already approved for diabetes and heart failure — based on what this trial found, is it something you would consider prescribing alongside my anthracycline treatment, or is the evidence still too early for that conversation?
5If protecting my heart during chemotherapy is a priority, are there other proven strategies or trials you'd recommend I look at alongside this one?
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
Left ventricular function assessed by echocardiography.
Timeframe: Evaluated at baseline and 4 months after initiation of chemotherapy.