EMPA Acute Heart Failure
EMPA Acute Heart Failure
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.
Inclusion Criteria:

 1. Age ≥ 18 years

 2. Patients with acute heart failure with associated signs or symptoms (dyspnea on
 exertion, orthopnea, paroxysmal dyspnea, peripheral oedema, chest x-ray with pulmonary
 congestion)

 3. Serum levels of NT-proBNP ≥ 1000 pg/ml within 48 hours of Informed Consent

 4. Written informed consent prior to study participation

 Exclusion Criteria:

 1. Type 1 diabetes

 2. Participants of child-bearing age without adequate contraception

 3. Pregnancy or lactating females

 4. Cardiogenic shock

 5. Acute coronary syndrome within 30 days prior to randomization

 6. Planned or recent percutaneous or surgical coronary intervention within 30 days prior
 to randomization

 7. Signs of ketoacidosis and/or hyperosmolar hyperglycemic syndrome (pH ≤ 7.30 and
 glucose >14 mmol/l and HCO3- ≤ 18 mmol/l)

 8. Signs of uncontrolled active infection

 9. Dyspnea due to non-cardiac causes (severe pulmonary disease, anemia, severe obesity),
 non-HF causes such as acute or chronic respiratory disorders

 10. Coronary artery disease with requirement for revascularization within the study period

 11. Renal impairment (GFR < 20 ml/min/1,73 m2)

 12. Known hepatic impairment (as evidenced by total bilirubin >3 mg/dL) or history of
 cirrhosis with evidence of portal hypertension (e.g., presence of esophageal varices)

 13. Uncontrolled thyroid disease

 14. Endocrinopathies like Graves' disease, acromegaly, Cushings' disease

 15. Hypertensive retinopathy or encephalopathy

 16. Bariatric surgery in last 2 years prior to randomization

 17. Patients in whom study participation is not deemed appropriate under consideration of
 clinical wellbeing by the principal investigator

 18. The subject is mentally or legally incapacitated

 19. The subject received an investigational drug within 30 days prior to inclusion into
 this study

 20. Urinary tract infections or significant formation of residual urine in medical history

 21. Patients with particular risk for ketoacidosis (alcohol abuse, pancreatitis,
 pancreatic insulin deficiency from any cause, caloric restriction etc.) or
 ketoacidosis in the past

 22. Frequent hypoglycaemic events (in the opinion of the investigator)

 23. Intolerance to Empagliflozin and excipients in Empagliflozin or rather placebo

 24. Patients with severe stenosis or regurgitation of the aortic, pulmonary or mitral
 valve