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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Empagliflozin 25 MG

    Drug

    Empagliflozin 25mg per os once daily for 30 days

  • Placebo

    Drug

    Placebo per os once daily for 30 days

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: EmpagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in average daily area under curve (AUC) for serum sodium concentration

Change in average daily AUC for serum sodium concentration

Time frame
4 days
2

Long-term serum sodium change (before/after treatment)

Absolute change in serum sodium concentration from baseline to end of treatment

Time frame
30 days

Secondary outcomes

1

Impact intervention on bodyweight

change of bodyweight

Time frame
30 days
2

Impact intervention on blood pressure

change of blood pressure

Time frame
30 days
3

Course of serum sodium level

Course of serum sodium level

Time frame
30 days
4

Change of plasma osmolality

Change of plasma osmolality

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Basel, Switzerland

Lead sponsor

Luzerner Kantonsspital

Collaborator

Centre Hospitalier Universitaire Vaudois

Collaborator