Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI i… (NCT03782259) | Clinical Trial Compass
CompletedPhase 4
Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2
United States62 participantsStarted 2019-02-26
Plain-language summary
There is an unmet need for Cardiovascular Disease (CVD) risk reduction in patients with Type 2 Diabetes. In recent trials there has been promising findings of more effective glucose management and reductions in overall CVD events and hospitalization for heart failure with SGLT-2 inhibition. Using the capability of cardiac MRI with T1- and T2-mapping in assessments of myocardial fibrosis and inflammation, the investigators propose to conduct a clinical trial to investigate the effects of SGLT-2 inhibition with dapagliflozin on myocardial strain, fibrosis and inflammation as assessed by cardiac MRI with T1- and T2-mapping in patients with type-2 diabetes.
Over approximately 12 months subjects will have 6 clinical visits at the investigators research clinic. During this time subjects will be randomized to receive either active 10mg dapagliflozin or a matching placebo. 2 MRI scans at one of the two University of Washington research imaging centers will take place. One at randomization and the second scan will occur approximately 12 months after the first scan.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men and women at least 18 years of age
✓. Subjects with type-2 diabetes history \>=5 years
✓. HbA1C 7-10% with glucose control medications including insulin, metformin or sulfonylurea
✓. Medically stable
✓. Willing to participate and sign informed consent.
Exclusion criteria
✕. Contraindication to MRI
✕. Currently or within last three months treatment with a SGLT2 inhibitor
✕. Currently taking glucagon-like peptide (GLP)-1 receptor antagonist