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
Study ID
NCT04541797
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 Years
Healthy Volunteers
Not accepted

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.
  • 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).
  • Stress Cardiac Magnetic Resonance — DIAGNOSTIC_TEST
    Imaging: All patients will have stress CMR examinations at recruitment.

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Nov 2024
Primary completion
May 8, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • 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).
  • 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.

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 ]

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