None listed
Conditions
Brief summary
Annually, between 10–15 million (3.3–5%) patients will experience an acute perioperative myocardial infarction (PMI) or myocardial injury following non-cardiac surgery. Clinically apparent events only represent <20% of heart injuries, with more patients sustaining subclinical myocardial injuries (MINS). Risk of morbidity and mortality significantly elevate after MINS, yet insufficient evidence exists to inform treatment recommendations. The SHIELD Trial aims to fill this evidence gap, guide MINS management, and improve post-surgical patient outcomes. The SHIELD Pilot will randomise participants to daily dapagliflozin/placebo (SGLT2i) for six months. Pilot data will be used to optimise the protocol for the definitive trial by evaluating of the acceptability and suitability of the intervention and study procedures and expected participant compliance with the study drug.
Interventions
Sodium-Glucose Cotransporter-2 inhibitor (SGLT2i), Dapagliflozin (FORXIGA; 10 mg) daily oral tablet for 6 months
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Aged 45 years or older • Able to speak, read, and/or understand English • Undergone one (or more) major non-cardiac surgery/ies (Appendix 1) • Sustained MINS as evidenced by a 24 hour postoperative troponin level exceeding the established prognostically significant threshold for the assay • Resumed normal oral diet • Provide written informed consent before enrolment • Able to be randomised within 14 days of meeting MINS criteria • Treating surgeon agrees that the patient is suitable for randomisation (neither requires intervention/surgery nor have any contraindication to intervention) • Local investigator agrees that the patient is suitable for randomisation
Exclusion criteria
• Pregnant, breastfeeding, or having childbearing potential and refusing to use a medically acceptable contraceptive measure for the trial period • Awaiting or planning for cardiac catheterisation or coronary artery bypass surgery • Hepatic disease (Childs Pugh B or C) or with ALT or AST > 3 times upper limit of normal • Renal disease (eGFR < 35 mL/min or Crea clearance of < 50 mL/min/m2) or end-stage renal disease requiring dialysis • Medical history that might limit the individual’s ability to take trial treatments for the duration of the study • Patients unwilling or unable to comply with the trial protocol • Any other specific reason leading to the investigator to deem them ineligible • Previously enrolled in the trial • If the responsible clinician is reasonably certain that the trial treatment is clearly indicated, or contraindicated for the participant • Hypersensitivity or known allergy to a drug in the dapagliflozin or other SGLT2i drug class • Currently or planned to receive heart failure or antidiabetic medication (SGLT2i, insulin or sulphonylureas drug classes) • Clinically dehydrated • History of hypotension • Type 1 diabetes • Type 2 Diabetes with recent or recurrent severe ketoacidosis, or hypoglycaemia • Intravenous immunosuppression in the last 3 months or on > 45mg prednisolone (or equivalent) • Active bladder cancer • History of Fournier’s Gangrene (necrotising fasciitis of the perineum)
Outcome results
None listed