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

NCT ID: NCT04541797

Last Updated: 2024-11-21

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2025-02-28

Brief 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.

Detailed Description

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.

Conditions

Type 2 Diabetes; Microvascular Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Control

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).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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).

Stress Cardiac Magnetic Resonance

Intervention Type: DIAGNOSTIC_TEST

Imaging: All patients will have stress CMR examinations at recruitment.

Intervention

Patients will be prescribed empagliflozin 10mg once a day and optimised medical therapy for 6 months and standard follow-up like the control group.

Group Type: EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type: DRUG

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.

Stress Cardiac Magnetic Resonance

Intervention Type: DIAGNOSTIC_TEST

Imaging: All patients will have stress CMR examinations at recruitment.

Interventions

Empagliflozin 10 MG

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.

Intervention Type: DRUG

Placebo

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).

Intervention Type: DRUG

Stress Cardiac Magnetic Resonance

Imaging: All patients will have stress CMR examinations at recruitment.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Empagliflozin; Stress CMR

Eligibility 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The University of Hong Kong

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

UW 19-010

Identifier Type: -

Identifier Source: org_study_id