Type 2 DiabetesCATCH-EMNCT04541797
Stress Cardiac Magnetic Resonance of Asymptomatic Type 2 Diabetics with Cardiovascular High Risk to Measure Empagliflozin Impact on Myocardial Blood Flow (CATCH-EM)
A study testing Empagliflozin 10 MG and Stress Cardiac Magnetic Resonance in people with Type 2 Diabetes and Microvascular Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Type 2 Diabetes, Microvascular Coronary Artery Disease
- What is being tested?
- Empagliflozin 10 MG and Stress Cardiac Magnetic Resonance
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Oct 2020to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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, 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%
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Empagliflozin 10 MG, Placebo, Stress Cardiac Magnetic Resonance
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin 10 MGDrug
Also called Empagliflozin
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.
PlaceboDrug
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 ResonanceDiagnostic test
Also called Stress CMR
Imaging: All patients will have stress CMR examinations at recruitment.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Empagliflozin 10 MG; Diagnostic Test: Stress Cardiac Magnetic Resonance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 36 months
Cut-off value for maximum upslope ratio to predict ≥10% increase in myocardial blood flow as result of empagliflozin.
Measured: 36 months
Cut-off value for myocardial perfusion index to predict ≥10% increase in myocardial blood flow as result of empagliflozin.
Measured: 36 months
Changes in coronary artery plaque volumes between patients receiving empagliflozin and patients not receiving empagliflozin
Measured: 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.
Measured: 36 months
Left ventricular ejection fraction.
Measured: 36 months
Left ventricular volumes.
Measured: 36 months
Left ventricular myocardial mass.
Measured: 36 months
Right ventricular ejection fraction.
Measured: 36 months
Right ventricular volumes.
Measured: 36 months
Right ventricular myocardial mass.
Measured: 36 months
Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure).
Measured: 36 months
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.
Measured: 36 months
Improvement in exercise tolerance through performing a cardiopulmonary exercise test.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Oct 2020
- Primary completion8 May 2024
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blinded randomised control trial study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541797
- Sponsor's protocol ID
- UW 19-010
- Acronym
- CATCH-EM
- Status last verified
- Nov 2024
- First submitted
- 8 Jul 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04541797
- Acronym / sponsor ID
- CATCH-EM / UW 19-010
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 9 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- double blinded randomised control trial study
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo, Diagnostic Test: Stress Cardiac Magnetic ResonancePatients 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 | Experimental | Drug: Empagliflozin 10 MG, Diagnostic Test: Stress Cardiac Magnetic ResonancePatients will be prescribed empagliflozin 10mg once a day and optimised medical therapy for 6 months and standard follow-up like the control group. |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Onset of type 2 diabetes at ≥30yrs old with no history of ketoacidosis
- 40-90yrs old
- Any 2 risk factors which include:
- HbA1c ≥ 6.5% and <10.0%
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin 10 MGAlso: EmpagliflozinIntervention 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. | Drug | Intervention |
| PlaceboControl 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). | Drug | Control |
| Stress Cardiac Magnetic ResonanceAlso: Stress CMRImaging: All patients will have stress CMR examinations at recruitment. | Diagnostic test | Control, Intervention |
Primary outcome
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.
Time frame: 36 months
Cut-off value for maximum upslope ratio to predict ≥10% increase in myocardial blood flow as result of empagliflozin.
Time frame: 36 months
Cut-off value for myocardial perfusion index to predict ≥10% increase in myocardial blood flow as result of empagliflozin.
Time frame: 36 months
Changes in coronary artery plaque volumes between patients receiving empagliflozin and patients not receiving empagliflozin
Time frame: 36 months
10 secondary outcomes
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
Left ventricular ejection fraction.
Time frame: 36 months
Left ventricular volumes.
Time frame: 36 months
Left ventricular myocardial mass.
Time frame: 36 months
Right ventricular ejection fraction.
Time frame: 36 months
Right ventricular volumes.
Time frame: 36 months
Right ventricular myocardial mass.
Time frame: 36 months
Composite of empagliflozin therapy complication (eg. Urinary tract infection, acute renal failure).
Time frame: 36 months
Progression in patient symptoms diagnoses.
Time frame: 36 months
Improvement in exercise tolerance through performing a cardiopulmonary exercise test.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empagliflozin 10 MG and Stress Cardiac Magnetic Resonance in people with Type 2 Diabetes and Microvascular Coronary Artery Disease, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.