In this study the investigators are aiming to treat patients with acute heart failure with or without diabetes with Empagliflozin or placebo. Given the beneficial effects of Empagliflozin on heart failure hospitalization in the EMPA-REG OUTCOME trial, the investigators do expect a similar beneficial effect to be present in patients with acute heart failure. Acute heart failure is a state of hydropic decompensation resulting in dyspnea and congestions, caused by different etiologies of cardiac disease. Recompensation is reached by application of diuretic drugs and fluid restriction.
In the present study patients will be randomized into 2 groups (standard of care + Empagliflozin 10 mg/d or standard of care + placebo). Cardiac output will be assessed by a medical device for noninvasive monitoring of hemodynamic parameters (cardiac output, systemic vascular resistance, stroke volume and blood pressure) using finger cuff technology for pulse contour analysis. These investigations will inform about Empagliflozin dependent effects on hemodynamic and cardiac function in patients with acute heart failure. The investigation will further assess the therapeutic efficacy of Empagliflozin on heart failure symptoms using objective (respiratory rate, oxygen requirement, peak expiratory flow rate, urinary volume, body weight, diuretic requirement, length of hospital stay) and well accepted, patient orientated secondary endpoints. In addition, metabolic regulators and parameters relevant for cardiac function and substrate metabolism will be assessed to further investigate possible mechanisms of Empagliflozin-dependent actions on cardiac function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
Standard of Care + Empagliflozin: 10 mg (tablets) once daily
Standard of Care + Placebo: Matching Placebo (tablets) once daily
Department of Internal Medicine I RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, Germany
effect of Empagliflozin 10mg qd versus placebo on cardiac output in patients with acute heart failure
by ClearSight System
Time frame: 30 days
Hemodynamics
Systemic vascular resistance (mmHg⋅min⋅mL-1)
Time frame: 30 days
Hemodynamics
Stroke volume (ml/beat)
Time frame: 30 days
Exercise Capacity
Hand grip
Time frame: 30 days
Cardio vascular
blood pressure (mmHg)
Time frame: 30 days
Effect of Empagliflozin on systemic quality of life
Quality of life questionnaire
Time frame: 30 days
Effect of Empagliflozin on hospitalization due to cardiovascular causes or readmission for heart failure or renal failure
length of initial hospital stay
Time frame: 30 days
Effect of Empagliflozin on death due to cardiovascular causes
days alive and out of hospital
Time frame: 30 days
Urine
24 h sodium excretion (mmol/day)
Time frame: 30 days
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Body weight
body weight (kg)
Time frame: 30 days
Cardio vascular
24 h heart rate (bpm)
Time frame: 30 days
Blood
NT-proBNP (ng/l)
Time frame: 30 days
Blood
cystatin C(mg/dl)
Time frame: 30 days
Blood
serum levels of Glucose, Glucagon, Insulin, Total-Ketone bodies, Hydroxybutyrate, Aldosterone, Free fatty acidy (mg/dl)
Time frame: 30 days
Blood
Hemoglobin, Haematocrit, Erythropoietin
Time frame: 30 days
Respiratory rate
breaths/min
Time frame: 30 days
Diuretic response
Δ weight kg/\[(total i.v. dose)/40mg\]+\[(total oral dose)/80mg)\] furosemide
Time frame: 30 days
Kidney injury risk score
by NephroCheck® (defined by TIMP-2 x IGFBP7 in urine)
Time frame: 30 days
change of microbiome
stool sample
Time frame: 30 days
Patient-reported dyspnea
visual analogue scale (VAS), 7 point categorical Likert scale
Time frame: 30 days
Peak expiratory flow rate
Time frame: 30 days
Oxygen
Saturation (%)
Time frame: 30 days
Oxygen
delivered (l/min)
Time frame: 30 days
Clinical judged diuretic requirement
Time frame: 30 days
Blood
eGFR
Time frame: 30 days
Blood
Lactate, pH, HCO3-
Time frame: 30 days
Blood
Serum osmolarity, Potassium, Chloride
Time frame: 30 days
Effect of Empagliflozin 10 mg daily on Left ventricular systolic function
ejection fraction
Time frame: 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
Time frame: 30 days