| Trial ID: | L6996 |
| Source ID: | NCT04541797
|
| Associated Drug: |
Empagliflozin 10 Mg
|
| 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
|
| Status: |
ACTIVE_NOT_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes|Microvascular Coronary Artery Disease
|
| Interventions: |
DRUG: Empagliflozin 10 MG|DRUG: Placebo|DIAGNOSTIC_TEST: Stress Cardiac Magnetic Resonance
|
| Outcome Measures: |
Primary: 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: 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., 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., 36 months|Improvement in exercise tolerance through performing a cardiopulmonary exercise test., 36 months
|
| Sponsor/Collaborators: |
Sponsor: The University of Hong Kong
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
160
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
|
| Start Date: |
2020-10-01
|
| Completion Date: |
2025-02-28
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-21
|
| Locations: |
The University of Hong Kong, Hong Kong, Hong Kong
|
| URL: |
https://clinicaltrials.gov/show/NCT04541797
|
