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Trial registered on ANZCTR
Registration number
ACTRN12621000355875
Ethics application status
Approved
Date submitted
23/02/2021
Date registered
30/03/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
30/03/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomised trial of Empagliflozin and Left ventricular diastolic function in Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D)
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Scientific title
Randomised trial of Empagliflozin and Left ventricular diastolic function in adults with Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D)
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Secondary ID [1]
303536
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None
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Universal Trial Number (UTN)
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Trial acronym
RELACS-T2D
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus
320870
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Acute coronary syndrome
320871
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Condition category
Condition code
Cardiovascular
318691
318691
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0
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Coronary heart disease
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Metabolic and Endocrine
319027
319027
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Following an acute coronary syndrome (ACS), participants with diabetes will be randomised 1:1 to one of the following two groups:
1) Empagliflozin (Jardiance®) 10 mg daily (open-label) orally for 6 months.
2) No sodium-glucose co-transporter 2 (SGLT2) inhibitor treatment (control).
The design allows clinicians to consider other glucose-lowering therapies as part of usual care if glycaemic control is suboptimal. Empagliflozin, a commonly used medication, is approved by the Therapeutic Goods Administration (TGA) and is Pharmaceutical Benefits Scheme (PBS) subsidised for patients with type 2 diabetes and HbA1c >7% despite treatment with either metformin or a sulfonylurea. Adherence to medications will be monitored at the follow-up and may involve checking with the participant's pharmacy for dispensing record. At the 6-month follow-up visit, participants not randomised to empagliflozin will be commenced on a SGLT2 inhibitor if eligible based on PBS criteria as part of usual care.
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Intervention code [1]
319820
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Treatment: Drugs
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Comparator / control treatment
Following an ACS, participants with diabetes will be randomised 1:1 to one of the following two groups:
1) Empagliflozin (Jardiance®) 10 mg daily (open-label).
2) No sodium-glucose co-transporter 2 (SGLT2) inhibitor treatment (control) - these participants will be treated using other glucose-lowering medications.
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Control group
Active
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Outcomes
Primary outcome [1]
326632
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Left ventricular diastolic function (mitral valve peak E-wave and A-wave velocities, mitral valve early diastolic deceleration time, septal and lateral annular early diastolic (e’) velocities, left atrial volume and diastolic functional reserve) as measured by echocardiography
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Assessment method [1]
326632
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Timepoint [1]
326632
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Baseline and 6 months
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Primary outcome [2]
326932
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Left ventricular mass indexed to body surface area as measured by echocardiography
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Assessment method [2]
326932
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Timepoint [2]
326932
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Baseline and 6 months
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Secondary outcome [1]
392213
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Left ventricular systolic function (ejection fraction and global longitudinal strain) as measured by echocardiography
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Assessment method [1]
392213
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Timepoint [1]
392213
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Baseline and 6 months
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Secondary outcome [2]
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Exercise time and metabolic equivalents (METs) as measured by stress testing
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Assessment method [2]
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Timepoint [2]
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Baseline and 6 months
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Secondary outcome [3]
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Biomarkers (N-terminal pro B-type natriuretic peptide, glycated haemoglobin, inflammation) as measured by plasma analysis
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Assessment method [3]
393172
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Timepoint [3]
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Baseline and 6 months
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Eligibility
Key inclusion criteria
• Type 2 diabetes already on metformin and/or sulfonylurea therapy unless contraindicated.
• Admission to hospital for ACS, defined as ST-segment myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina, and undergoing coronary.
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Minimum age
20
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• History of diabetic ketoacidosis.
• Baseline HbA1c <7% or >10%.
• Current SGLT2 inhibitor or glucagon-like peptide-1 agonist use or prior use within the last 6 months.
• Atrial fibrillation or other serious cardiac arrhythmias (ventricular tachycardia, ventricular fibrillation or complete heart block).
• Moderate or severe valvular heart disease or previous valve surgery.
• Renal impairment with an estimated glomerular filtration rate of <45 ml/min/1.73m2.
• Hospital re-admission for a cardiac-related event during the trial, such as myocardial infarction, arrhythmia, heart failure, myocarditis, endocarditis, pericarditis or cardiac procedure/surgery.
• Unstable ACS.
• Active foot ulcer or gangrene.
• Planned coronary intervention or bypass grafting during time of follow-up.
• Unable to perform supine bicycle stress echocardiography.
• Hypertension (systolic blood pressure >200 and/or diastolic blood pressure >110 mmHg).
• Inability to provide informed consent.
• Pregnant or breastfeeding women.
• Known hypersensitivity to empagliflozin.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
5/04/2021
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Actual
13/10/2021
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Date of last participant enrolment
Anticipated
31/03/2022
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Actual
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Date of last data collection
Anticipated
31/12/2022
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Actual
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Sample size
Target
80
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Accrual to date
10
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
307959
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Charities/Societies/Foundations
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Name [1]
307959
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Diabetes Research WA
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Address [1]
307959
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Ainslie House, 48 Murray St, Perth WA 6000
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Country [1]
307959
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Australia
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Primary sponsor type
Hospital
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Name
Fiona Stanley Hospital
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Address
11 Robin Warren Dr, Murdoch WA 6150
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Country
Australia
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Secondary sponsor category [1]
308675
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None
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Name [1]
308675
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None
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Address [1]
308675
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None
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Country [1]
308675
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
307954
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South Metropolitan Health Service Human Research Ethics Committee
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Ethics committee address [1]
307954
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South Metropolitan Health Service Executive
Level 2, Education Building, Fiona Stanley Hospital
14 Barry Marshall Parade
MURDOCH Western Australia 6150
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Ethics committee country [1]
307954
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Australia
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Date submitted for ethics approval [1]
307954
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09/01/2021
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Approval date [1]
307954
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26/03/2021
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Ethics approval number [1]
307954
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Summary
Brief summary
Sodium-glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce heart failure hospitalisation in patients with type 2 diabetes (T2D) at high cardiovascular risk and in patients with heart failure (HF) with reduced ejection fraction without or without diabetes. However, the mechanisms by which SGLT2 inhibitors reduce the risk of HF remains unclear. Previous studies have demonstrated that SGLT2 inhibitors can reduce left ventricular (LV) mass and improve LV diastolic function in stable outpatients with T2D and in patients with HF with reduced ejection fraction. We recently performed the first study to assess the effects of empagliflozin (an SGLT2 inhibitor) on LV function following an acute coronary syndrome (ACS) in patients with T2D. The observational study found that empagliflozin reduces LV mass and improves LV diastolic function in this cohort, which means that empagliflozin could potentially improve the heart’s pumping function after a heart attack or an angina episode. This had led to the design of the Randomised trial of Empagliflozin and Left Ventricular diastolic function in Acute Coronary Syndrome and Type 2 Diabetes (RELACS-T2D).
Following an ACS, 80 participants with T2D at Fiona Stanley Hospital (FSH) will be randomised 1:1 in this open-label trial to either 1) Empagliflozin or 2) no SGLT2 inhibitor therapy. Diastolic stress echocardiography (DSE) using supine bicycle will be performed at baseline and at 6 months follow-up. Echocardiography will be performed by certified sonographers and reported by a consultant Cardiologist who are both blinded to treatment allocation. Results at follow-up will be compared to baseline by a blinded investigator to assess for significant changes in LV function between groups. Non-fasting blood samples will be collected at baseline and follow-up and analysed to detect significant associations. We hypothesise that empagliflozin treatment can reduce adverse LV remodelling and improve LV diastolic function following an ACS in patients with T2D.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
109026
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Prof Girish Dwivedi
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Address
109026
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Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
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Country
109026
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Australia
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Phone
109026
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+61 861524130
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Fax
109026
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Email
109026
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[email protected]
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Contact person for public queries
Name
109027
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Dr Nick Si Rui Lan
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Address
109027
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Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
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Country
109027
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Australia
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Phone
109027
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+61 861522222
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Fax
109027
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Email
109027
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[email protected]
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Contact person for scientific queries
Name
109028
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Dr Nick Si Rui Lan
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Address
109028
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Fiona Stanley Hospital
11 Robin Warren Dr, Murdoch WA 6150
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Country
109028
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Australia
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Phone
109028
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+61 861522222
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Fax
109028
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Email
109028
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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