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

NCT04541797 | Active Not Recruiting

• 1 other identifier: UW 19-010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes; Microvascular Coronary Artery Disease

Outcome Measures

Primary Outcomes (4)

• 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.

  36 months

• Cut-off value for maximum upslope ratio to predict ≥10% increase in myocardial blood flow as result of empagliflozin.

  36 months

• Cut-off value for myocardial perfusion index to predict ≥10% increase in myocardial blood flow as result of empagliflozin.

  36 months

• Changes in coronary artery plaque volumes between patients receiving empagliflozin and patients not receiving empagliflozin

  36 months

Secondary Outcomes (10)

• Change in myocardial blood flow (MBF) in the intervention arm patients comparing patients with positive stress CMR to patients with negative stress CMR.

  36 months

• Left ventricular ejection fraction.

  36 months

• Left ventricular volumes.

  36 months

• Left ventricular myocardial mass.

  36 months

• Right ventricular ejection fraction.

  36 months

Study Arms (2)

Control

PLACEBO COMPARATOR

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).

Drug: Placebo; Diagnostic Test: Stress Cardiac Magnetic Resonance

Intervention

EXPERIMENTAL

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

Drug: Empagliflozin 10 MG; Diagnostic Test: Stress Cardiac Magnetic Resonance

Interventions

Empagliflozin 10 MG 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.

Also known as: Empagliflozin

Intervention

Placebo 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).

Control

Stress Cardiac Magnetic Resonance DIAGNOSTIC_TEST

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

Also known as: Stress CMR

Control; Intervention

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: A stratified block randomisation process will be used. Two blocks will be created for randomisation which are 1) Positive stress CMR patients who did not have significant coronary artery disease; 2) Negative stress CMR patients. This will ensure equal spread of these two groups of patients into the control and intervention arm. Patients will be randomised into control and intervention arms. 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 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blinded randomised control trial study

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: September 9, 2020
• Study Start: October 1, 2020
• Primary Completion: May 8, 2024
• Study Completion: February 28, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

HK (1)