Stress Cardiac Magnetic Resonance of Asymptomatic Type 2 Diabetics With Cardiovascular High Risk to Measure Empagliflozin Impact on Myocardial Blood Flow (CATCH-EM)

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Empagliflozin

Criteria

Inclusion Criteria:

• Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis

• 40-90yrs old

• Any 2 risk factors which include:

i) Smoking (ie. current or ex-smokers) ii) Dyslipidaemia (defined as low density lipoprotein ≥2.6mmol/L, triglyceride >1.7mmol/L or decreased high density lipoprotein cholesterol <1.04mmol/L [man] or <1.29mmol/L [woman] or on lipid-lowering agent)(17, 18) iii) Hypertension (ie. systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg or patients treated for hypertension) iv) Obesity (using definition adapted for chinese ethnicity, body mass index >25kg/m2)(19) v) Family history of premature heart disease (defined as 1st degree relative [ie. parent or sibling] with development of atherosclerotic cardiovascular disease or cardiovascular related death <55 years of age in male and <65 years of age in female)

• HbA1c ≥ 6.5% and <10.0%

Exclusion Criteria:

• Angina pectoris or chest discomfort

• Prior coronary artery bypass grafts

• Coronary artery stenting within 6 months of study enrolment

• Previous myocardial infarct

• Any contraindication for stress CMR testing

• Renal impairment with eGFR <45ml/min/1.73m2

• Limited life expectancy <5 years, for example due to pulmonary disease, cancer or significant hepatic failure

• Contraindication to dual antiplatelet therapy

• Contraindication to empagliflozin or other SGLT2 inhibitors

• Unable to take empagliflozin

• Patients currently on empagliflozin or given empagliflozin in the last 6 months

• Planned need for concomitant cardiac surgery or coronary intervention

• Refusal or inability to sign an informed consent.

• Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits