Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000146493
Ethics application status
Approved
Date submitted
3/06/2024
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Surgery-related Heart Injury Evaluation: Limiting Damage (SHIELD) Pilot
Scientific title
Surgery-related Heart Injury Evaluation: Limiting Damage (SHIELD) – a Phase II parallel arm blinded pilot study investigating the role of dapagliflozin in reducing major adverse cardiovascular events following myocardial injury after non-cardiac surgery: The SHIELD Pilot.
Secondary ID [1] 312276 0
None
Universal Trial Number (UTN)
U1111-1308-8329
Trial acronym
The SHIELD Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Health 333998 0
Condition category
Condition code
Cardiovascular 330669 330669 0 0
Coronary heart disease
Cardiovascular 330670 330670 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sodium-Glucose Cotransporter-2 inhibitor (SGLT2i), Dapagliflozin (FORXIGA; 10 mg) daily oral tablet for 6 months
Intervention code [1] 328738 0
Treatment: Drugs
Comparator / control treatment
Placebo-controlled. Placebo tablets will consist of the direct compression excipient Prosolv. To ensure robust blinding, placebos will be identical in appearance with tablet tooling and film coating to match FORXIGA 10mg tablets.
Control group
Placebo

Outcomes
Primary outcome [1] 338416 0
Evaluation of recruitment capability and sample characteristics assessed as a composite outcome.
Timepoint [1] 338416 0
Monthly assessments for six months of active recruitment at each site.
Primary outcome [2] 338417 0
Evaluation and refinement of data collection procedures and outcome measures a composite outcome.
Timepoint [2] 338417 0
Monthly assessments for six months of active recruitment at each site.
Primary outcome [3] 338418 0
Evaluation of the acceptability and suitability of the intervention and study procedures as a composite outcome.
Timepoint [3] 338418 0
Monthly assessments for six months of active recruitment at each site.
Secondary outcome [1] 435833 0
This is an additional primary outcome. Evaluation of the resources and ability to manage and implement the study and intervention as a composite outcome.
Timepoint [1] 435833 0
Study completion at 6 months post final patient enrolment at site.
Secondary outcome [2] 436692 0
This is an additional primary outcome. Monitoring of safety and adverse event endpoints for the Factor 1 (DAPT) arm of the trial as a composite incidence of significant bleeding complications.
Timepoint [2] 436692 0
Two weeks, 3 months and 6 months post commencement of trial drug. From first patient enrolled until final patient completes 6 months of study drug administration.
Secondary outcome [3] 436693 0
This is an additional primary outcome. Monitoring of safety and adverse event endpoints for the Factor 2 (SGLT2i) arm of the trial as a composite of known side-effects for the drug class.
Timepoint [3] 436693 0
Two weeks, 3 months and 6 months post commencement of trial drug. From first patient enrolled until final patient completes 6 months of study drug administration.

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA

Funding & Sponsors
Funding source category [1] 316663 0
Other Collaborative groups
Name [1] 316663 0
Australian and New Zealand College of Anaesthetists
Country [1] 316663 0
Australia
Funding source category [2] 316664 0
Charities/Societies/Foundations
Name [2] 316664 0
ANZCA Foundation
Country [2] 316664 0
Australia
Funding source category [3] 316665 0
Government body
Name [3] 316665 0
Metro North Health and Hospital Service
Country [3] 316665 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318849 0
None
Name [1] 318849 0
Address [1] 318849 0
Country [1] 318849 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315443 0
Metro North Health Human Research Ethics Committee B
Ethics committee address [1] 315443 0
Ethics committee country [1] 315443 0
Australia
Date submitted for ethics approval [1] 315443 0
01/07/2024
Approval date [1] 315443 0
08/10/2024
Ethics approval number [1] 315443 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134714 0
A/Prof Jonathon Fanning
Address 134714 0
The Prince Charles Hospital, 627 Rode Rd, Chermside QLD 4032
Country 134714 0
Australia
Phone 134714 0
+61 410 408 777
Fax 134714 0
Email 134714 0
[email protected]
Contact person for public queries
Name 134715 0
Jonathon Fanning
Address 134715 0
The Prince Charles Hospital, 627 Rode Rd, Chermside QLD 4032
Country 134715 0
Australia
Phone 134715 0
+61 410 408 777
Fax 134715 0
Email 134715 0
[email protected]
Contact person for scientific queries
Name 134716 0
Jonathon Fanning
Address 134716 0
The Prince Charles Hospital, 627 Rode Rd, Chermside QLD 4032
Country 134716 0
Australia
Phone 134716 0
+61 410 408 777
Fax 134716 0
Email 134716 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Pilot trial data will not be available until after the publication of the definitive trial.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.