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Clinical Trial Details

Trial ID: L5742
Source ID: NCT03554200
Associated Drug: Empagliflozin
Title: EMPA Acute Heart Failure
Acronym:
Status: TERMINATED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Acute Heart Failure
Interventions: DRUG: Empagliflozin|DRUG: Placebo
Outcome Measures: Primary: effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure, by ClearSight System, 30 days | Secondary: Hemodynamics, Systemic vascular resistance (mmHg⋅min⋅mL-1), 30 days|Hemodynamics, Stroke volume (ml/beat), 30 days|Exercise Capacity, Hand grip, 30 days|Cardio vascular, blood pressure (mmHg), 30 days|Effect of Empagliflozin on systemic quality of life, Quality of life questionnaire, 30 days|Effect of Empagliflozin on hospitalization due to cardiovascular causes or readmission for heart failure or renal failure, length of initial hospital stay, 30 days|Effect of Empagliflozin on death due to cardiovascular causes, days alive and out of hospital, 30 days|Urine, 24 h sodium excretion (mmol/day), 30 days|Body weight, body weight (kg), 30 days|Cardio vascular, 24 h heart rate (bpm), 30 days|Blood, NT-proBNP (ng/l), 30 days|Blood, cystatin C(mg/dl), 30 days|Blood, serum levels of Glucose, Glucagon, Insulin, Total-Ketone bodies, Hydroxybutyrate, Aldosterone, Free fatty acidy (mg/dl), 30 days|Blood, Hemoglobin, Haematocrit, Erythropoietin, 30 days|Respiratory rate, breaths/min, 30 days|Diuretic response, Δ weight kg/\[(total i.v. dose)/40mg\]+\[(total oral dose)/80mg)\] furosemide, 30 days|Kidney injury risk score, by NephroCheck® (defined by TIMP-2 x IGFBP7 in urine), 30 days|change of microbiome, stool sample, 30 days|Patient-reported dyspnea, visual analogue scale (VAS), 7 point categorical Likert scale, 30 days|Peak expiratory flow rate, 30 days|Oxygen, Saturation (%), 30 days|Oxygen, delivered (l/min), 30 days|Clinical judged diuretic requirement, 30 days|Blood, eGFR, 30 days|Blood, Lactate, pH, HCO3-, 30 days|Blood, Serum osmolarity, Potassium, Chloride, 30 days|Effect of Empagliflozin 10 mg daily on Left ventricular systolic function, ejection fraction, 30 days|Effect of Empagliflozin 10 mg daily on Left ventricular diastolic function, 2D and 3D parameter global strain rate E by echocardiography and by standardized parameter E/E' and left atrial (LA) volume, 30 days
Sponsor/Collaborators: Sponsor: RWTH Aachen University | Collaborators: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 19
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2018-06-11
Completion Date: 2020-10-29
Results First Posted:
Last Update Posted: 2022-10-27
Locations: Department of Internal Medicine I RWTH Aachen University Hospital, Aachen, NRW, 52074, Germany
URL: https://clinicaltrials.gov/show/NCT03554200