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Cardiovascular effects of empagliflozin in diabetes mellitus

Cardiovascular effects of empagliflozin in diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN82391603
Enrollment
60
Registered
2018-10-16
Start date
2018-08-29
Completion date
Unknown
Last updated
2022-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart disease in patients with type 2 diabetes and previous myocardial infarction Circulatory System

Interventions

This is a crossover study to characterise the cardiac effects of sitagliptin and empagliflozin on CMR imaging biomarkers and glycaemic status in patients with type 2 diabetes with a history of myocard

Sponsors

University of Leeds
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Type 2 diabetes mellitus 2. Metformin as single or dual therapy 3. Recent heart attack (48mmol/ml 5. 18-84 years old 6. Ability to provide informed consent

Exclusion criteria

Exclusion criteria: 1. Previous coronary artery bypass grafting (CABG) 2. Need for further revascularisation 3. Contra-indication to CMR scanning (some pacemakers, intraorbital debris, intraauricular implants, intracranial clips etc) 4. Contra-indication to Adenosine 5. Known allergy to contrast medium (gadolinium) 6. Renal dysfunction with eGFR< 60 7. Obesity where girth exceeds the scanner bore 8. Pregnancy or breastfeeding 9. Inability to lie flat for CMR scan

Design outcomes

Primary

MeasureTime frame
Myocardial perfusion reserve in remote myocardium, measured by cardiac MRI at baseline, 12 and 24 weeks

Secondary

MeasureTime frame
1. Myocardial perfusion reserve in infarcted territory 2. Extracellular volume fraction 3. Capillary permeability 4. Relationship between glycaemic markers and LV perfusion parameters 5. Aortic distensibility Secondary outcome measures will be measured by cardiac MRI at baseline and at weeks 12 and 24. Secondary outcome measure 4 will also be measured at approximately 2 weeks before baseline and at weeks 10 and 22.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 15, 2026