Logo 1 Logo 2

Clinical Trial Details

Trial ID: L2596
Source ID: NCT03485092
Associated Drug: Empagliflozin 10 Mg
Title: Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects
Acronym: SUGAR-DM-HF
Status: COMPLETED
Study Results: NO
Results:
Conditions: Heart Failure|Diabetes Mellitus
Interventions: DRUG: Empagliflozin 10 MG|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: Left Ventricular End Systolic Volume Index (LVESVI), Cardiac structure measured by left ventricular end-systolic volume index measured by cardiac magnetic resonance imaging as mL/m2, 36 weeks|left ventricular global longitudinal strain (GLS), Cardiac structure measured by left ventricular global longitudinal strain measured by cardiac magnetic resonance imaging GLS%, 36 weeks | Secondary: Left ventricular end diastolic volume index (LVEDVI), Left ventricular end diastolic volume index (LVEDVI) measured by Cardiac MR in ml/m2, 36 weeks|Left ventricular ejection fraction (LVEF), Left ventricular ejection fraction (LVEF) measured by Cardiac MR in percentage, 36 weeks|Left ventricular mass index (LVMI), Left ventricular mass index (LVMI) measured by cardiac MR in grams/m2, 36 weeks|Left ventricular global function index (LVGFI), Left ventricular global function index (LVGFI) measured by cardiac MR in percentage, 36 weeks|Left atrial volume index (LAVI), Left atrial volume index (LAVI) measured by cardiac MR in ml/m2, 36 weeks|Microvascular perfusion, Microvascular perfusion measured by Gadolinium enhanced Cardiac magnetic resonance imaging measured as ml/min/g, 36 weeks|Extracellular volume fraction, Extracellular volume fraction measured by Gadolinium enhanced Cardiac magnetic resonance imaging measured as %, 36 weeks|Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS), Kansas City Cardiomyopathy Questionnaire Total Symptom score (TSS) measured by mean overall difference and responder analysis (higher score = better outcome), 36 weeks|6 minute walk distance (Exercise Capacity), Exercise capacity measured by six minute walk test measured in m, 36 weeks|Pulmonary congestion, Pulmonary congestion as B-lines measured using lung ultrasound, 36 weeks|Biomarker profile -glycated haemaglobin (HbA1c), biomarker profile of HbA1c (mmol/mol), 36 weeks|Biomarker profile - creatine, biomarker profile of creatine (umol/L), 36 weeks|Biomarker profile - estimated glomerular filtration rate (eGFR), biomarker profile of eGFR (ml/min/m2), 36 weeks|Biomarker profile - liver function tests (LFTs), biomarker profile of LFTs (U/L), 36 weeks|Biomarker profile - uric acid, biomarker profile of uric acid (umol/L), 36 weeks|Intensification of diuretic therapy, Intensification of diuretic therapy through addition and/or increase dose of diuretic medication, 36 weeks | Other: Left ventricular global longitudinal strain (GLS), Left ventricular global longitudinal strain (GLS) measured by CMR tagging measured in percentage, 36 weeks|Left ventricular global circumferential strain (GCS), Left ventricular global circumferential strain (GCS) measured in CMR featured-tracking and tagging in percentage, 36 weeks|Left ventricular global radial strain (GRS), Left ventricular global radial strain (GRS)measured in CMR featured-tracking and tagging in percentage, 36 weeks|total renal blood flow measured by magnetic resonance imaging, total renal blood flow measure using cardiac magnetic resonance imaging measured as ml/min/100g, 36 weeks|Renal fibrosis, Renal fibrosis measured by T1 mapping in MRI in miiliseconds, 36 weeks|Bioelectrical impedance analysis, Bioelectrical impedance analysis in percentage, 36 weeks|Clinical composite outcome of death, hospitalisation with worsening heart failure, ED visit for worsening heart failure, outpatient worsening of heart failure accompanied by increase in HF therapy, Clinical composite outcome of death, hospitalisation with worsening heart failure, ED visit for worsening heart failure, outpatient worsening of heart failure accompanied by increase in HF therapy, 36 weeks|Clinical composite analysed using Win-ratio approach, Clinical composite (analysed using Win-ratio approach) outcome of death, hospitalisation with worsening heart failure, ED visit for worsening heart failure, outpatient worsening of heart failure accompanied by increase in HF therapy, KCCQ-TSS \>5-point decrease, or no decrease, \>30% in NT-proBNP from baseline, 36 weeks|Left ventricular diastolic function, Left ventricular diastolic function measured by echocardiogram, 36 weeks|DNA and epigenetics, DNA and epigenetic analysis, 36 weeks
Sponsor/Collaborators: Sponsor: NHS Greater Glasgow and Clyde | Collaborators: University of Glasgow
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 105
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-03-16
Completion Date: 2020-03-28
Results First Posted:
Last Update Posted: 2020-09-18
Locations: Queen Elizabeth University Hospital, Glasgow, Scotland, G51 4TF, United Kingdom
URL: https://clinicaltrials.gov/show/NCT03485092