| Trial ID: | L5508 |
| Source ID: | NCT03782259
|
| Associated Drug: |
Dapagliflozin
|
| Title: |
Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03782259/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Myocardial Fibrosis|Myocardial Inflammation
|
| Interventions: |
DRUG: dapagliflozin|OTHER: Placebo
|
| Outcome Measures: |
Primary: Extracellular Volume Fraction (ECV), Cardiac MRI using T1-mapping is capable of quantifying myocardial extracellular volume (ECV), a surrogate of fibrosis, with excellent inter- and intra-observer variability. Cardiac fibrosis was assessed by cardiac MRI T1 mapping to calculate ECV at two timepoints, baseline and at approximately 1 year. ECV combines native and contrast-enhanced T1 mapping. Extracellular Volume (ECV) maps were generated offline using MATLAB software. ECV was calculated from native and post-contrast T1 values for blood and myocardial tissue, the partition coefficient lambda (λ), and hematocrit using the following formulas: ECV = λ(1-hematocrit); λ = (1/T1 myocardium post-contrast-1/T1 myocardium-native)/(1/T1 blood post-contrast-1/T1 blood-native)., Approximately 12 Months|Global Myocardial Strain, Global myocardial strain measured from cardiac MRI with T1-mapping at two timepoints. MRI at Randomization and MRI at approximately 12 Months. Myocardial strain measurements with feature tracking will be performed to measure myocardial strain from the Balanced Steady State Free Precession (bSSFP) short-axis and long-axis cine images. Long-axis cine images will be further used to compute global myocardial strain. Ancova test with adjusted for baseline global myocardial strain will be used to compare change in global myocardial strain over 12 months between 2 treatment groups. Global myocardial strain reported as longitudinal, radial, and circumferential at baseline and 1 year., Approximately 12 Months | Secondary: T2 Relaxation Time, Change from baseline in T2 relaxation time measured from cardiac MRI with T2-mapping at two timepoints. MRI at Randomization and MRI at approximately 12 Months, Approximately 12 Months | Other: Fasting Glucose, Fasting glucose assessed at Baseline and every 3 months for approximately 12 months, Baseline and 12 months reported, Approximately 12 Months|HbA1C, Hemoglobin A1c (HbA1c) assessed at Baseline and every 3 months for approximately 12 months, Baseline and 12 months reported, Approximately 12 Months|hsCRP, Inflammatory marker hsCRP assessed at Baseline and every 6 months for approximately 12 months, Baseline and 12 months reported, Approximately 12 Months
|
| Sponsor/Collaborators: |
Sponsor: University of Washington | Collaborators: AstraZeneca
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
62
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: SCREENING
|
| Start Date: |
2019-02-26
|
| Completion Date: |
2022-11-16
|
| Results First Posted: |
2023-12-29
|
| Last Update Posted: |
2023-12-29
|
| Locations: |
University of Washington, Seattle, Washington, 98104, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03782259
|
