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Clinical Trial Details

Trial ID: L4399
Source ID: NCT02932436
Associated Drug: Empagliflozin
Title: Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics
Acronym: EmDia
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Diastolic Dysfunction
Interventions: DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: difference in E/E' ratio between 12 weeks after baseline and at baseline, difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline, 12 weeks | Secondary: difference in E/E' ratio (change from baseline (V1) to 1 week follow-up), difference in E/E' ratio (change from baseline (V1) to 1 week follow-up (2D-echocardiography), 1 week|difference in Left ventricular systolic function (LVEF), difference in Left ventricular systolic function (LVEF) from baseline to week 1, 1 week|difference in Left ventricular systolic function (LVEF), difference in Left ventricular systolic function (LVEF) from baseline to week 12, 12 weeks|difference in Left end-diastolic volume (LEDV), difference in Left end-diastolic volume (LEDV) from baseline to week 1, 1 week|difference in Left end-diastolic volume (LEDV), difference in Left end-diastolic volume (LEDV) from baseline to week 12, 12 weeks|difference in Carotid-femoral pulse wave velocity, difference in Carotid-femoral pulse wave velocity (cf-PWV, vascular explorer - calculated) from baseline to week 1, 1 week|difference in Carotid-femoral pulse wave velocity, difference in Carotid-femoral pulse wave velocity (cf-PWV, vascular explorer - calculated) from baseline to week 12, 12 weeks|difference in Augmentation index (AIx), difference in Augmentation index (AIx, vascular explorer) from baseline to week 1, 1 week|difference in Augmentation index (AIx), difference in Augmentation index (AIx, vascular explorer) from baseline to week 12, 12 week|difference in Arterial stiffness index (SI), difference in Arterial stiffness index (SI, photo plethysmography) from baseline to week 1, 1 week|difference in Arterial stiffness index (SI), difference in Arterial stiffness index (SI, photo plethysmography) from baseline to week 12, 12 weeks|difference in Reflection index, difference in Reflection index (photo plethysmography) from baseline to week 1, 1 week|difference in Reflection index, difference in Reflection index (photo plethysmography) from baseline to week 12, 12 weeks|difference in Brain natriuretic peptide (BNP), difference in Brain natriuretic peptide (BNP) from baseline to week 1, 1 week|difference in Brain natriuretic peptide (BNP), difference in Brain natriuretic peptide (BNP) from baseline to week 12, 12 weeks|difference in High sensitive troponin I (hs TnI), difference in High sensitive troponin I (hs TnI) from baseline to week 1, 1 week|difference in High sensitive troponin I (hs TnI), difference in High sensitive troponin I (hs TnI) from baseline to week 12, 12 weeks|difference in High sensitive C-reactive protein (hs CRP), difference in High sensitive C-reactive protein (hs CRP) from baseline to week 1, 1 week|difference in High sensitive C-reactive protein (hs CRP), difference in High sensitive C-reactive protein (hs CRP) from baseline to week 12, 12 weeks|difference in E/E' ratio (change from baseline (V1) to 12 weeks follow-up) in the subgroup of patients with eGFR 45-59 ml/min/1.73 m², difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline in the subgroup of patients with eGFR 45-59 ml/min/1.73 m², 12 weeks|difference in E/E' ratio (change from baseline (V1) to 12 weeks follow-up) in the subgroup of patients with HbA1c 6.5%-6.9%, difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline in the subgroup of patients with with HbA1c 6.5%-6.9%, 12 weeks | Other: difference in biomarkers of cardiac diseases, changes between baseline and follow-up after 1 week in biomarkers of cardiac diseases, 1 week|difference in biomarkers of cardiac diseases, changes between baseline and follow-up after 12 weeks in biomarkers of cardiac diseases, 12 weeks|difference in biomarkers of vascular diseases, changes between baseline and follow-up after 1 week in biomarkers of vascular diseases, 1 week|difference in biomarkers of vascular diseases, changes between baseline and follow-up after 12 weeks in biomarkers of vascular diseases, 12 weeks|difference in biomarkers of metabolic/diabetic status, changes between baseline and follow-up after 1 week in biomarkers of metabolic/diabetic status, 1 week|difference in biomarkers of metabolic/diabetic status, changes between baseline and follow-up after 12 weeks in biomarkers of metabolic/diabetic status, 12 weeks|changes in vascular/endothelial function, changes between baseline and follow-up after 1 week in vascular/endothelial function, 1 week|changes in vascular/endothelial function, changes between baseline and follow-up after 12 weeks in vascular/endothelial function, 12 weeks|changes in carotid atherosclerosis, changes between baseline and follow-up after 1 week in carotid atherosclerosis, 1 week|changes in carotid atherosclerosis, changes between baseline and follow-up after 12 weeks in carotid atherosclerosis, 12 weeks|changes in pulmonary function, changes between baseline and follow-up after 1 week in pulmonary function, 1 week|changes in pulmonary function, changes between baseline and follow-up after 12 weeks in pulmonary function, 12 weeks|changes in ophthalmological diseases, changes between baseline and follow-up after 1 week in ophthalmological diseases, 1 week|changes in ophthalmological diseases, changes between baseline and follow-up after 12 weeks in ophthalmological diseases, 12 weeks|changes in psychosomatic diseases, changes between baseline and follow-up after 1 week in psychosomatic diseases, 1 week|changes in psychosomatic diseases, changes between baseline and follow-up after 12 weeks in psychosomatic diseases, 12 weeks|association analysis for selected SNPs, association analysis for selected SNPs (measured at baseline), baseline
Sponsor/Collaborators: Sponsor: Johannes Gutenberg University Mainz | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 144
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2016-10-10
Completion Date: 2020-08-31
Results First Posted:
Last Update Posted: 2021-04-19
Locations: Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kardiologie, Präventive Kardiologie und Medizinische Prävention, Mainz, 55131, Germany
URL: https://clinicaltrials.gov/show/NCT02932436