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NCT04541797Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 21 Nov 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
160 (estimated)
First submitted
8 Jul 2020
Start date
1 Oct 2020
Primary completion date
8 May 2024
Lead sponsor
The University of Hong Kong
NCT number
NCT04541797

What you commit to

  • Study type: Interventional
  • Planned participants: 160
  • From 1 Oct 2020 to the primary completion date, 8 May 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior coronary artery bypass grafts
  • Previous myocardial infarct
  • Contraindication to dual antiplatelet therapy
  • Contraindication to empagliflozin or other SGLT2 inhibitors
  • Patients currently on empagliflozin or given empagliflozin in the last 6 months
  • Planned need for concomitant cardiac surgery or coronary intervention

Other illness

  • Angina pectoris or chest discomfort

Lab values

  • Renal impairment with eGFR \<45ml/min/1.73m2

Age

  • Limited life expectancy \<5 years, for example due to pulmonary disease, cancer or significant hepatic failure

Other

  • Coronary artery stenting within 6 months of study enrolment
  • Any contraindication for stress CMR testing
  • Unable to take empagliflozin
  • 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

Who the study is looking for

  • 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%

Age in the registry: 40 years to 90 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
The University of Hong Kong
Coordinator of this site? Confirm its status
Hong KongHong KongUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.