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Clinical Trial Details

Trial ID: L5808
Source ID: NCT02998970
Associated Drug: Empagliflozin
Title: Effects of Empagliflozin on Cardiac Structure in Patients With Type 2 Diabetes
Acronym: EMPA-HEART
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Diabetes|Cardiovascular Disease
Interventions: DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: Left Ventricular (LV) mass Changes, Changes in Left Ventricular (LV) mass (indexed to BSA) at 6 months in patients with Type 2 diabetes who receive empagliflozin vs. placebo. This will be measured using CMRI., 6 months | Secondary: LV end-diastolic volume, Changes in LV end-diastolic volume (indexed to BSA) at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin. This will be measured using CMRI., 6 months|End-systolic volume (indexed to BSA), Changes in end-systolic volume (indexed to BSA) at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin. This will be measured using CMRI., 6 months|Left Ventricular Ejection Fraction (LVEF), Changes LVEF at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin. This will be measured using CMRI., 6 months|Regional LV diastolic function, Changes in Regional LV diastolic function at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin. This will be measured using CMRI., 6 months|Regional LV systolic function, Changes in Regional LV systolic function at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin. This will be measured using CMRI., 6 months|Aortic pulse wave velocity and distensibility, Changes in aortic pulse wave velocity and distensibility (as arterial stiffness) at baseline and at 6 months in patients with type 2 diabetes treated with empagliflozin., 6 months|Biomarkers, Changes on a panel of biomarkers involved in the pathophysiology of heart failure at baseline, 1 months and 6 months, in patients with type 2 diabetes treated with empagliflozin., 6 months|Plasma catecholamine levels, Changes in plasma catecholamine levels at baseline, 1 months and 6 months, in patients with type 2 diabetes treated with empagliflozin., 6 months
Sponsor/Collaborators: Sponsor: Unity Health Toronto | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 97
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: DIAGNOSTIC
Start Date: 2017-01
Completion Date: 2018-09
Results First Posted:
Last Update Posted: 2018-08-15
Locations: St. Michael's Hospital, Toronto, Ontario, M5B 1W8, Canada
URL: https://clinicaltrials.gov/show/NCT02998970