None listed
Conditions
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.
Interventions
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 Adm
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.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed