The study design is a double blinded randomised control trial study that aims to conduct a randomised controlled trial of empagliflozin and determine if empagliflozin will improve myocardial blood flow in asymptomatic high risk type 2 diabetic patients. Also, to determine a cut-off using maximum upslope ratio and myocardial perfusion reserve index in which patients would demonstrate an improvement in myocardial blood flow.
It is unknown whether empagliflozin will improve myocardial blood flow and resolve myocardial ischaemia caused by microvascular coronary artery disease in asymptomatic patients with type 2 diabetes.This study proposes to perform a randomised controlled trial to compare optimised medical therapy against empagliflozin in addition to optimised medical therapy to improve myocardial blood flow as measured by stress CMR. This trial would provide evidence if 10mg of empagliflozin given for 6 months could be an indicated treatment in asymptomatic high risk type 2 diabetic patients using stress CMR. The duration of 6 months is slightly longer than the mouse study (ie. 5 months) which showed an improvement in myocardial blood flow but not too long that the risk of increased patient withdrawal from the study will occur. All patients will undergo coronary CT angiography in order to assess degree of coronary artery narrowing non-invasively before allocation to the control or intervention group. Patients will also undergo coronary CT angiography at the end of the study after 6 months of placebo or empagliflozin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
160
Intervention group: Patients will be prescribed empagliflozin 10mg once a day and optimised medical therapy for 6 months and standard follow-up like the control group.
Control group: Patients will have placebo and optimised medical therapy and will continue to have protocol driven therapy and follow-up appointments (currently 1 appointment every 3 months).
Imaging: All patients will have stress CMR examinations at recruitment.
The University of Hong Kong
Hong Kong, Hong Kong
Difference in myocardial blood flow as measured by stress CMR (ie. maximum upslope ratio and myocardial perfusion reserve index) between patients receiving empagliflozin and patients not receiving empagliflozin.
Time frame: 36 months
Cut-off value for maximum upslope ratio to predict ≥10% increase in myocardial blood flow as result of empagliflozin.
Time frame: 36 months
Cut-off value for myocardial perfusion index to predict ≥10% increase in myocardial blood flow as result of empagliflozin.
Time frame: 36 months
Changes in coronary artery plaque volumes between patients receiving empagliflozin and patients not receiving empagliflozin
Time frame: 36 months
Change in myocardial blood flow (MBF) in the intervention arm patients comparing patients with positive stress CMR to patients with negative stress CMR.
Time frame: 36 months
Left ventricular ejection fraction.
Time frame: 36 months
Left ventricular volumes.
Time frame: 36 months
Left ventricular myocardial mass.
Time frame: 36 months
Right ventricular ejection fraction.
Time frame: 36 months
Right ventricular volumes.
Time frame: 36 months
Right ventricular myocardial mass.
Time frame: 36 months
Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure).
Time frame: 36 months
Progression in patient symptoms diagnoses.
The Seattle Angina Questionnaire (SAQ) will be administered at time of baseline CMR and at follow-up CMR in order to determine if there is an improvement in patient symptoms.
Time frame: 36 months
Improvement in exercise tolerance through performing a cardiopulmonary exercise test.
Time frame: 36 months
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