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Breast CancerSPRINTNCT07070765

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

A study testing Sodium-glucose transport-2 (SGLT-2) inhibitors and Standard medical treatment in people with Breast Cancer, run by University of Aberdeen at 2 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Sodium-glucose transport-2 (SGLT-2) inhibitors and Standard medical treatment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
70 participants
Where
2 sitesUnited Kingdom
Study dates
12 Dec 2025to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Patients with prior exposure to anthracyclines.
  • Patients who cannot read and understand English.
  • Patients who are pregnant

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sylvia Kamya, MBChB contact

+441224559573

sylvia.kamya@nhs.scot

Amelia Rudd, PhD contact

+441224559573

a.e.rudd@abdn.ac.uk

United Kingdom2 sites, 2 recruiting
  • Cardiac Research Office, Aberdeen Royal Infirmary

    Aberdeen, Aberdeenshire, AB25 2ZD

    Dana Dawson, PhD, 01224 437969, dana.dawson@abdn.ac.uk

    Amelia Rudd, HND, 01224 559573, a.e.rudd@abdn.ac.uk

    Recruiting
  • University of Aberdeen

    Aberdeen, AB25 2ZD

    Sylvia Kamya, MBChB, +441224559573, sylvia.kamya@nhs.scot

    Amelia Rudd, PhD, a.e.rudd@abdn.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Sodium-glucose transport-2 (SGLT-2) inhibitors, Standard medical treatment
Keywords
breast cancer, chemotherapy, anthracycline, sodium-glucose transporter type 2 inhibition
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium-glucose transport-2 (SGLT-2) inhibitorsDrug

    Also called Dapagliflozin 10mg in addition to standard clinical care

    Dapagliflozin 10mg in addition to standard clinical care

  • Standard medical treatmentOther

    Also called Standard clinical care

    Standard clinical care

Study groups in NCT07070765
Study groupRoleWhat they receive
Sodium-glucose transporter type 2 inhibition treatment armActive comparatorSodium-glucose transporter type 2 inhibition plus standard clinical care for the duration of chemotherapy treatment
Receives: Drug: Sodium-glucose transport-2 (SGLT-2) inhibitors
Standard clinical care placebo treatment armPlacebo comparatorStandard clinical care for the duration of chemotherapy treatment
Receives: Other: Standard medical treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac energetics

    In vivo myocardial phosphocreatine/gamma-adenosine triphosphate (PCr/yATP) ratio by cardiac 31P cardiac magnetic resonance spectroscopy

    Measured: From enrolment to the end of treatment at the end of approximately 22 weeks

Secondary outcomes (1)
  1. Myocardial Ca2+ influx

    Myocardial Ca2+ influx assessed with manganese-enhanced magnetic resonance imaging (MEMRI)

    Measured: From enrolment to the end of treatment at the end of approximately 22 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start12 Dec 2025
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07070765
Sponsor's protocol ID
3-033-23
Acronym
SPRINT
Status last verified
Jul 2025
First submitted
26 Jun 2025
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Baris VO, Dincsoy AB, Gedikli E, Zirh S, Muftuoglu S, Erdem A. Empagliflozin Significantly Prevents the Doxorubicin-induced Acute Cardiotoxicity via Non-antioxidant Pathways. Cardiovasc Toxicol. 2021 Sep;21(9):747-758. doi: 10.1007/s12012-021-09665-y. Epub 2021 Jun 5.

    PubMed 34089496
  • Maejima Y. SGLT2 Inhibitors Play a Salutary Role in Heart Failure via Modulation of the Mitochondrial Function. Front Cardiovasc Med. 2020 Jan 8;6:186. doi: 10.3389/fcvm.2019.00186. eCollection 2019.

    PubMed 31970162
  • Santos-Gallego CG, Requena-Ibanez JA, San Antonio R, Ishikawa K, Watanabe S, Picatoste B, Flores E, Garcia-Ropero A, Sanz J, Hajjar RJ, Fuster V, Badimon JJ. Empagliflozin Ameliorates Adverse Left Ventricular Remodeling in Nondiabetic Heart Failure by Enhancing Myocardial Energetics. J Am Coll Cardiol. 2019 Apr 23;73(15):1931-1944. doi: 10.1016/j.jacc.2019.01.056.

    PubMed 30999996
  • Selvaraj S, Fu Z, Jones P, Kwee LC, Windsor SL, Ilkayeva O, Newgard CB, Margulies KB, Husain M, Inzucchi SE, McGuire DK, Pitt B, Scirica BM, Lanfear DE, Nassif ME, Javaheri A, Mentz RJ, Kosiborod MN, Shah SH; DEFINE-HF Investigators. Metabolomic Profiling of the Effects of Dapagliflozin in Heart Failure With Reduced Ejection Fraction: DEFINE-HF. Circulation. 2022 Sep 13;146(11):808-818. doi: 10.1161/CIRCULATIONAHA.122.060402. Epub 2022 May 23.

    PubMed 35603596
  • Gaborit B, Ancel P, Abdullah AE, Maurice F, Abdesselam I, Calen A, Soghomonian A, Houssays M, Varlet I, Eisinger M, Lasbleiz A, Peiretti F, Bornet CE, Lefur Y, Pini L, Rapacchi S, Bernard M, Resseguier N, Darmon P, Kober F, Dutour A. Effect of empagliflozin on ectopic fat stores and myocardial energetics in type 2 diabetes: the EMPACEF study. Cardiovasc Diabetol. 2021 Mar 1;20(1):57. doi: 10.1186/s12933-021-01237-2.

    PubMed 33648515
  • Thirunavukarasu S, Jex N, Chowdhary A, Hassan IU, Straw S, Craven TP, Gorecka M, Broadbent D, Swoboda P, Witte KK, Cubbon RM, Xue H, Kellman P, Greenwood JP, Plein S, Levelt E. Empagliflozin Treatment Is Associated With Improvements in Cardiac Energetics and Function and Reductions in Myocardial Cellular Volume in Patients With Type 2 Diabetes. Diabetes. 2021 Dec;70(12):2810-2822. doi: 10.2337/db21-0270. Epub 2021 Oct 5.

    PubMed 34610982
  • Maslov MY, Chacko VP, Hirsch GA, Akki A, Leppo MK, Steenbergen C, Weiss RG. Reduced in vivo high-energy phosphates precede adriamycin-induced cardiac dysfunction. Am J Physiol Heart Circ Physiol. 2010 Aug;299(2):H332-7. doi: 10.1152/ajpheart.00727.2009. Epub 2010 May 21.

    PubMed 20495142
  • Govender J, Loos B, Marais E, Engelbrecht AM. Mitochondrial catastrophe during doxorubicin-induced cardiotoxicity: a review of the protective role of melatonin. J Pineal Res. 2014 Nov;57(4):367-80. doi: 10.1111/jpi.12176. Epub 2014 Oct 18.

    PubMed 25230823
  • Koleini N, Kardami E. Autophagy and mitophagy in the context of doxorubicin-induced cardiotoxicity. Oncotarget. 2017 Jul 11;8(28):46663-46680. doi: 10.18632/oncotarget.16944.

    PubMed 28445146
  • Goormaghtigh E, Chatelain P, Caspers J, Ruysschaert JM. Evidence of a complex between adriamycin derivatives and cardiolipin: possible role in cardiotoxicity. Biochem Pharmacol. 1980 Nov 1;29(21):3003-10. doi: 10.1016/0006-2952(80)90050-7. No abstract available.

    PubMed 7458950
  • Heck SL, Mecinaj A, Ree AH, Hoffmann P, Schulz-Menger J, Fagerland MW, Gravdehaug B, Rosjo H, Steine K, Geisler J, Gulati G, Omland T. Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy (PRADA): Extended Follow-Up of a 2x2 Factorial, Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Candesartan and Metoprolol. Circulation. 2021 Jun 22;143(25):2431-2440. doi: 10.1161/CIRCULATIONAHA.121.054698. Epub 2021 May 16.

    PubMed 33993702
  • Jones LW, Haykowsky MJ, Swartz JJ, Douglas PS, Mackey JR. Early breast cancer therapy and cardiovascular injury. J Am Coll Cardiol. 2007 Oct 9;50(15):1435-41. doi: 10.1016/j.jacc.2007.06.037. Epub 2007 Sep 24.

    PubMed 17919562
  • Lyon AR, Lopez-Fernandez T, Couch LS, Asteggiano R, Aznar MC, Bergler-Klein J, Boriani G, Cardinale D, Cordoba R, Cosyns B, Cutter DJ, de Azambuja E, de Boer RA, Dent SF, Farmakis D, Gevaert SA, Gorog DA, Herrmann J, Lenihan D, Moslehi J, Moura B, Salinger SS, Stephens R, Suter TM, Szmit S, Tamargo J, Thavendiranathan P, Tocchetti CG, van der Meer P, van der Pal HJH; ESC Scientific Document Group. 2022 ESC Guidelines on cardio-oncology developed in collaboration with the European Hematology Association (EHA), the European Society for Therapeutic Radiology and Oncology (ESTRO) and the International Cardio-Oncology Society (IC-OS). Eur Heart J. 2022 Nov 1;43(41):4229-4361. doi: 10.1093/eurheartj/ehac244. No abstract available.

    PubMed 36017568
  • Felker GM, Thompson RE, Hare JM, Hruban RH, Clemetson DE, Howard DL, Baughman KL, Kasper EK. Underlying causes and long-term survival in patients with initially unexplained cardiomyopathy. N Engl J Med. 2000 Apr 13;342(15):1077-84. doi: 10.1056/NEJM200004133421502.

    PubMed 10760308
  • Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available.

    PubMed 27567406

Questions about this trial

What is this clinical trial studying?

A study testing Sodium-glucose transport-2 (SGLT-2) inhibitors and Standard medical treatment in people with Breast Cancer, run by University of Aberdeen at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sylvia Kamya, MBChB (+441224559573, sylvia.kamya@nhs.scot), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac energetics (time frame: From enrolment to the end of treatment at the end of approximately 22 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07070765, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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