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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    172
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 1 August 2021
diabetes
heparin
fluid restriction
heart failure
cirrhosis
vasopressin
serum sodium
empagliflozin
hyponatremia
sglt2

Summary

Hyponatremia is the most common electrolyte derangement occurring in hospitalized patients. It is usually classified as hypovolemic, euvolemic or hypervolemic. The most common aetiology of euvolemic hyponatremia is the syndrome of inappropriate antidiuresis (SIAD). Hypervolemic hyponatremia is common in patients with congestive heart failure (CHF) (10-27%) and liver cirrhosis (up to approximately 50%). In SIAD, the regulation of arginine vasopressin (AVP) secretion is impaired which leads to free water retention. In CHF and liver cirrhosis, the effective arterial blood volume is decreased leading to non-osmotic baroreceptor mediated AVP release and consecutive free water retention.

Current treatments of euvolemic and hypervolemic hyponatremia, including the most used treatment fluid restriction, are of limited efficacy. Sodium-Glucose-Co-Transporter 2 (SGLT2) inhibitors reduce glucose reabsorption in the proximal tubule, resulting in glucosuria and consecutive osmotic diuresis. A placebo-controlled randomized trial of our group has shown that a short-term, i.e. a 4-days administration of the SGLT2 inhibitor empagliflozin (Jardiance) in addition to fluid restriction was effective in increasing the serum sodium concentration in 87 patients with SIAD-induced hyponatremia. The effect of empagliflozin (Jardiance) without additional fluid restriction is however not yet known. Large randomized controlled trials have shown that SGLT2 inhibitors reduced hospitalization for heart failure in patients with, and more recently without type 2 diabetes. No studies have investigated the effect of SGLT2 inhibitors in hypervolemic hyponatremia.

To evaluate the effect of empagliflozin (Jardiance) in eu- and hypervolemic hyponatremia, a randomized placebo-controlled study is needed.

Details
Condition Renal Failure, Pituitary Disease, Nephropathy, Hepatic Insufficiency, SIADH, Hyponatremia, Hepatic Failure, Kidney Disease (Pediatric), Low Blood Sodium (Hyponatremia), Kidney Failure (Pediatric), Pituitary Disorders, Kidney Disease, Kidney Failure, Liver Failure, renal insufficiency
Treatment Placebo, Empagliflozin 25 mg
Clinical Study IdentifierNCT04447911
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on1 August 2021

Eligibility

Yes No Not Sure

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 <30 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
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
previous enrolment into the current study
fasting or other reasons preventing medication intake
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
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