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

Primary Purpose

Type 2 Diabetes, Microvascular Coronary Artery Disease

Status

Recruiting

Phase

Not Applicable

Locations

Hong Kong

Study Type

Interventional

Intervention

Empagliflozin 10 MG

Placebo

Stress Cardiac Magnetic Resonance

About this trial

This is an interventional diagnostic trial for Type 2 Diabetes

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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:
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

Sites / Locations

The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Intervention

Arm Description

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).

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

Outcomes

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.

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

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

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.

Left ventricular ejection fraction.

Left ventricular volumes.

Left ventricular myocardial mass.

Right ventricular ejection fraction.

Right ventricular volumes.

Right ventricular myocardial mass.

Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure).

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.

Improvement in exercise tolerance through performing a cardiopulmonary exercise test.

Full Information

NCT ID

NCT04541797

First Posted

July 8, 2020

Last Updated

May 8, 2023

Sponsor

The University of Hong Kong

1. Study Identification

Unique Protocol Identification Number

NCT04541797

Brief Title

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

Acronym

CATCH-EM

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)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 1, 2020 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes, Microvascular Coronary Artery Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

double blinded randomised control trial study

Masking

ParticipantInvestigator

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.

Allocation

Randomized

Enrollment

160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

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).

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Intervention Name(s)

Empagliflozin 10 MG

Other Intervention Name(s)

Empagliflozin

Intervention Description

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

Intervention Name(s)

Placebo

Intervention Description

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

Diagnostic Test

Intervention Name(s)

Stress Cardiac Magnetic Resonance

Other Intervention Name(s)

Stress CMR

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

36 months

Title

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

Time Frame

36 months

Title

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

Time Frame

36 months

Secondary Outcome Measure Information:

Title

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

Title

Left ventricular ejection fraction.

Time Frame

36 months

Title

Left ventricular volumes.

Time Frame

36 months

Title

Left ventricular myocardial mass.

Time Frame

36 months

Title

Right ventricular ejection fraction.

Time Frame

36 months

Title

Right ventricular volumes.

Time Frame

36 months

Title

Right ventricular myocardial mass.

Time Frame

36 months

Title

Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure).

Time Frame

36 months

Title

Progression in patient symptoms diagnoses.

Description

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

Title

Improvement in exercise tolerance through performing a cardiopulmonary exercise test.

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ming-Yen NG, BMBS

Phone

(+852) 22552524

myng2@hku.hk

Facility Information:

Facility Name

The University of Hong Kong

City

Hong Kong

Country

Hong Kong

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ming-Yen NG, BMBS

Phone

(+852) 22554524

myng2@hku.hk

12. IPD Sharing Statement

Learn more about this trial

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

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