Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)

Who is this study for? Adult patients with euvolemic and hypervolemic hyponatremia
What treatments are being studied? Empagliflozin
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Centre Hospitalier Universitaire Vaudois (CHUV)
RECRUITING
Lausanne
Kantonsspital Luzern
RECRUITING
Lucerne
Contact Information
Primary
Mirjam Christ-Crain, Prof
Mirjam.Christ-Crain@usb.ch
+41 61 328 70 80
Time Frame
Start Date: 2021-02-04
Estimated Completion Date: 2026-02
Participants
Target number of participants: 172
Treatments
Experimental: Empagliflozin
Empagliflozin (Jardiance)® 25mg per os once daily for 30 days
Placebo_comparator: Placebo
Placebo (Lactose tablet) per os once daily for 30 days
Sponsors
Collaborators: Centre Hospitalier Universitaire Vaudois, Luzerner Kantonsspital
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov

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