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

Sponsor

The University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04541797

Collaborator

(none)

160

Enrollment

Location

Arms

Anticipated Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Microvascular Coronary Artery Disease	Drug: Empagliflozin 10 MG Drug: Placebo Diagnostic Test: Stress Cardiac Magnetic Resonance	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

double blinded randomised control trial studydouble blinded randomised control trial study

Masking:

Double (Participant, Investigator)

Masking Description:

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.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 1, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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).	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). Diagnostic Test: Stress Cardiac Magnetic Resonance Imaging: All patients will have stress CMR examinations at recruitment. Other Names: Stress CMR
Experimental: 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.	Drug: 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. Other Names: Empagliflozin Diagnostic Test: Stress Cardiac Magnetic Resonance Imaging: All patients will have stress CMR examinations at recruitment. Other Names: Stress CMR

Arm

Intervention/Treatment

Placebo Comparator: 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).

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).

Diagnostic Test: Stress Cardiac Magnetic Resonance

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

Other Names:

Stress CMR

Experimental: 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.

Drug: 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.

Other Names:

Empagliflozin

Diagnostic Test: Stress Cardiac Magnetic Resonance

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

Other Names:

Stress CMR

Outcome Measures

Primary Outcome Measures

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]

Secondary Outcome Measures

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]
Right ventricular volumes. [36 months]
Right ventricular myocardial mass. [36 months]
Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure). [36 months]
Progression in patient symptoms diagnoses. [36 months]
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.
Improvement in exercise tolerance through performing a cardiopulmonary exercise test. [36 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
40-90yrs old
Any 2 risk factors which include:

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,

1. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

The University of Hong Kong

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04541797

Other Study ID Numbers:

UW 19-010

First Posted:

Sep 9, 2020

Last Update Posted:

Jan 10, 2022

Last Verified:

Dec 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Coronary Artery Disease

Empagliflozin

Study Results

No Results Posted as of Jan 10, 2022