Dapagliflozin to prevent heart damage from anthracycline chemotherapy
Sodium-glucose Transporter Type 2 Inhibition in Anthracycline-related Cardiotoxicity - SPRINT
This research will see if taking dapagliflozin during anthracycline chemotherapy lowers the chance of heart damage in adults with breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | University of Aberdeen Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Aberdeen, Aberdeenshire and 1 other locations) |
| Trial ID | NCT07070765 on ClinicalTrials.gov |
What this trial studies
Adults with breast cancer who are scheduled for adjuvant or neoadjuvant anthracycline chemotherapy will take dapagliflozin daily during their treatment while a comparator group receives standard care. Cardiac magnetic resonance spectroscopy, imaging of heart function, and blood biomarkers will be used to quantify myocardial energetic deficits and detect cardiotoxicity. The trial enrolls patients aged 18–70 with low to medium cardiovascular risk who can give written informed consent and read English. Primary outcomes focus on rates of cardiac dysfunction and changes in myocardial energetics over the chemotherapy period.
Who should consider this trial
Good fit: Ideal candidates are adults (18–70) with breast cancer scheduled for adjuvant or neoadjuvant anthracycline chemotherapy who have low to medium cardiovascular risk and can provide informed consent.
Not a fit: Patients not receiving anthracyclines, those with high baseline cardiovascular disease, or those outside the age or risk criteria are unlikely to receive benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce anthracycline-related heart damage and help preserve long-term cardiac function for patients receiving chemotherapy.
How similar studies have performed: SGLT2 inhibitors have shown cardioprotective effects in heart failure and diabetes trials, but their use to prevent anthracycline cardiotoxicity is novel and currently supported mainly by pilot and preclinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with breast cancer between 18-70 years of age. * Patients with low to medium cardiovascular risk. * Patients scheduled for adjuvant or neo-adjuvant anthracycline therapy. * Patients who are able to give written informed consent to take part in the study. * Patients who can read and understand English. The current thresholds for defining cardiovascular risk for patients undergoing anthracycline chemotherapy are as follows: normal resting 12-lead electrocardiogram, plasma cardiac troponin I concentration \< 99th centile, serum brain natriuretic peptide concentration \<35 pg/mL or serum N-terminal pro-brain natriuretic peptide concentration \<125 pg/mL, left ventricular ejection fraction \>55%, global longitudinal strain \>-18% and healthy life-style (normal body-mass index, non-smoker). Low cardiovascular risk will allow for the presence of one abnormal life-style factor (body-mass index indicating obesity (\>30 kg/m2), current smoker or significant smoking history), or presence of only one of the following in the clinical history: hypertension, stage 1-2 chronic kidney disease, age 65-79 years, borderline left ventricular ejection fraction (50-54%) or elevated cardiac biomarkers. Medium cardiovascular risk will permit the combination of any 2-4 of the lifestyle or clinical history variables indicated above. Exclusion Criteria: * Patients with a known intolerance of dapagliflozin * Patients with high cardiovascular risk as specified by the most recent cardio-oncology guidelines. * Patients with significant renal impairment (estimated glomerular filtration rate \<45 mL/min/1.73 m2). * Patients with a previous cancer diagnosis. * Patients with known type 1 or 2 diabetes mellitus. We will not actively screen for diabetes. This is not done in clinical practice and there have been no issues. * Patients with a contraindication to magnetic resonance imaging. * Patients with prior exposure to anthracyclines. * Patients who cannot read and understand English. * Patients who are pregnant
Where this trial is running
Aberdeen, Aberdeenshire and 1 other locations
- Cardiac Research Office, Aberdeen Royal Infirmary — Aberdeen, Aberdeenshire, United Kingdom (Recruiting)
- University of Aberdeen — Aberdeen, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Dana Dawson, MPhil — University of Aberdeen
- Study coordinator: Sylvia Kamya, MBChB
- Email: sylvia.kamya@nhs.scot
- Phone: +441224559573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.