Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia

Launched by UNIVERSITY HOSPITAL, BASEL, SWITZERLAND · Jun 22, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called empagliflozin (Jardiance)® on patients who have low sodium levels in their blood, a condition known as hyponatremia. Hyponatremia can be caused by various health issues, including certain conditions of the heart, liver, or kidneys. The trial aims to find out if empagliflozin can help increase sodium levels in patients who have either euvolemic (normal fluid levels) or hypervolemic (excess fluid) hyponatremia, especially those who have not responded well to standard treatments like fluid restriction.

To participate in the trial, individuals should be between the ages of 65 and 74 and have chronic euvolemic or hypervolemic hyponatremia, with a sodium level below 135 mmol/L. However, there are several criteria that could exclude someone from joining, such as severe liver or kidney problems, uncontrolled conditions like diabetes, or recent participation in another study. Participants will receive either empagliflozin or a placebo (a substance with no active medication) and will be monitored for their response over time. This trial is important because it could lead to new treatment options for patients struggling with low sodium levels.

Gender

ALL

Eligibility criteria

• 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