Effekt des SGLT2 Inhibitors Empagliflozin auf Patienten mit euvolämischer und hypervolämischer Hyponatriämie - die EMPOWER Studie

Drug: Empagliflozin 25 MG;Drug: Placebo

Gender: All
Maximum age: N/A
Minimum age: 18 Years

Inclusion Criteria:

- chronic eu- OR hypervolemic non hyperosmolar (<300 mOsm/kg) hyponatremia (heparin plasma
sodium <135 mmol/L on day of inclusion)

Exclusion Criteria:

- known hypersensitivity or allergy to class of drugs or the investigational product,

- severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need
of intensive/intermediate care treatment at time of inclusion

- clinical hypovolemia

- Severe reduction of eGFR <20 mL/min/1,73 m2 (KDIGO G4 and G5) or end stage renal
disease

- Chronic liver insufficiency with Child Pugh Score =10 or decompensated liver cirrhosis
(jaundice, hepatorenal syndrome, encephalopathy, bleeding, ?)

- Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase
(ALT) >3x the upper limit of normal (ULN); or total bilirubin >2x ULN at time of
enrolment

- uncontrolled hypothyroidism

- uncontrolled adrenal insufficiency

- systolic blood pressure <90mmHg

- contraindication for lowering blood pressure

- diabetes mellitus type 1 or pancreatic diabetes mellitus

- treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on
inclusion day

- severe immunosuppression (leucocytes <2 G/l)

- peripheral arterial disease stage III-IV of the Fontaine Classification

- fasting or other reasons preventing medication intake

- previous enrolment into the current study

- participation in another intervention study

- pregnancy, breastfeeding, intention to become pregnant during the course of the study
or lack of safe contraception.

- end of life care