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Sodium-glucose Transporter Type 2 Inhibition in Anthracycline-related Cardiotoxicity - SPRINT

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Cardiotoxicity is heart damage that arises from certain drugs, such as those used for cancer treatment and develops in approximately 10% of patients with breast cancer who are treated with anthracyclines. It has been suggested that sodium-glucose transporter-2 (SGLT2) inhibitors may reduce the damage to the heart caused by anthracycline chemotherapy. The investigators wish to determine whether dapagliflozin (SGLT2 inhibitor) taken daily during chemotherapy will reduce the rate of cardiotoxicity.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
Cardiac Research Office, Aberdeen Royal Infirmary
RECRUITING
Aberdeen
University of Aberdeen
RECRUITING
Aberdeen
Contact Information
Primary
Sylvia Kamya, MBChB
sylvia.kamya@nhs.scot
+441224559573
Backup
Amelia Rudd, PhD
a.e.rudd@abdn.ac.uk
+441224559573
Time Frame
Start Date: 2025-12-12
Estimated Completion Date: 2028-10-31
Participants
Target number of participants: 70
Treatments
Active_comparator: Sodium-glucose transporter type 2 inhibition treatment arm
Sodium-glucose transporter type 2 inhibition plus standard clinical care for the duration of chemotherapy treatment
Placebo_comparator: Standard clinical care placebo treatment arm
Standard clinical care for the duration of chemotherapy treatment
Related Therapeutic Areas
Sponsors
Leads: University of Aberdeen
Collaborators: NHS Grampian

This content was sourced from clinicaltrials.gov