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

Sponsor: University of Aberdeen

NCT ID: NCT07070765

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Sodium-glucose transport-2 (SGLT-2) inhibitors (drug), Standard medical treatment (other)
How long the study runs
Study runs about 34 months (dates as stated)
About the drug or intervention
Sodium-glucose transport-2 (SGLT-2) inhibitors — drug: Dapagliflozin 10mg in addition to standard clinical care · Standard medical treatment — other: Standard clinical care
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by the University of Aberdeen, is looking at whether a medicine called dapagliflozin, a sodium-glucose transporter type 2 (SGLT2) inhibitor, can protect the heart from damage caused by anthracycline chemotherapy in adults with breast cancer. Anthracyclines are chemotherapy drugs that can sometimes harm the heart. Not stated — ask the trial team for full study details.

Who can take part

  • Adults aged 18 to 70 with breast cancer
  • Due to have anthracycline chemotherapy (before or after surgery)
  • Low or medium risk of heart problems, based on blood tests, heart scans and lifestyle checks
  • Able to give written informed consent
  • Able to read and understand English

Who may not be able to

  • Known intolerance to dapagliflozin
  • High risk of heart problems
  • Significant kidney problems
  • Any previous cancer diagnosis
  • Known type 1 or type 2 diabetes
  • Unable to have magnetic resonance imaging (MRI) scans
  • Previous treatment with anthracyclines
  • Unable to read and understand English
  • Pregnancy

What taking part involves

  • • Taking dapagliflozin (an SGLT2 inhibitor medicine) alongside anthracycline chemotherapy
  • • Heart checks are likely to include blood tests and heart scans, including magnetic resonance imaging (MRI) — exact details not stated, ask the trial team

Time commitment: Not stated — ask the trial team about how many visits there are, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
Female
Number of participants
70
Started
2025-12-12
Last checked
2025-07

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer
  • • NA - 70 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with breast cancer
  • • Female only

Where?

  • • Aberdeen - Cardiac Research Office, Aberdeen Royal Infirmary
  • • Aberdeen - University of Aberdeen

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

Cardiac dysfunction is a major complication of cancer drug therapies, affecting approximately 10% of patients treated with anthracyclines. It has the worst prognosis of all cardiomyopathies and is currently thought to be a consequence of an energetic based mitochondrial dysfunction. This energy deficit could potentially be ameliorated by the putative cardiometabolic benefits of sodium-glucose transporter type 2 inhibition. In pilot data from patients with breast cancer, the investigators have demonstrated that cardiac magnetic resonance spectroscopy can identify and quantify the myocardial energetic deficit associated with anthracycline therapy. The purpose of this study is to determine whether sodium-glucose transporter type 2 inhibition has the potential to reverse the myocardial energetic deficit associated with anthracycline toxicity.

Breast Cancer

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: Female only

What the study is looking for

  • ✓Patients with breast cancer between 18-70 years of age.
  • ✓Patients with low to medium cardiovascular risk.
  • ✓Patients scheduled for after surgery or neo-after surgery anthracycline therapy.
  • ✓Patients who are able to give written agreement to take part to take part in the study.
  • ✓Patients who can read and understand English.

Who cannot take part

  • ✗Patients with a known intolerance of dapagliflozin
  • ✗Patients with high cardiovascular risk as specified by the most recent cardio-oncology guidelines.
  • ✗Patients with significant kidney 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...
See the full 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 Is This Study? (2 UK sites)

Cardiac Research Office, Aberdeen Royal Infirmary

Aberdeen AB25 2ZD, United Kingdom

Recruiting
Site contact (verified)

University of Aberdeen

Aberdeen AB25 2ZD, United Kingdom

Recruiting
Site contact (verified)
Dana K Dawson, MPhilPrincipal Investigator
Amelia Rudd, PhDa.e.rudd@abdn.ac.uk

How to Get in Touch

Sylvia Kamya, MBChB

Sponsor contact

CONTACT

+441224559573 sylvia.kamya@nhs.scot

Amelia Rudd, PhD

Sponsor contact

CONTACT

+441224559573 a.e.rudd@abdn.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-07