Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia
Status:
Recruiting
Trial end date:
2023-02-01
Target enrollment:
Participant gender:
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.