Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study

  • STATUS
    Recruiting
  • days left to enroll
    75
  • participants needed
    16
  • sponsor
    University Hospital, Basel, Switzerland
Updated on 9 May 2021
diabetes
type 2 diabetes mellitus
vasopressin
serum sodium
fluid retention
osmolality
sglt2
siadh
antidiuretic
aquaretic

Summary

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia.

Especially chronic (>72h) SIADH is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary.

Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with chronic SIADH, as it resembles the aquaretic effect of urea.

The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic SIADH.

Details
Condition SIADH, Hyponatremia, Low Blood Sodium (Hyponatremia)
Treatment Placebo, Empagliflozin 25mg
Clinical Study IdentifierNCT03202667
SponsorUniversity Hospital, Basel, Switzerland
Last Modified on9 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adult patients (age 18 years) with hyponatremia (<133mmol/l) due to chronic
(>72h) SIADH defined as
serum osmolality <275mosm/kg
urine osmolality >100mosm/kg
urine sodium >30mmol/l

Exclusion Criteria

acute (<72h) or transient hyponatremia
severe symptomatic hyponatremia in need of hospital treatment
diabetes mellitus type 1
uncontrolled hypothyroidism
uncontrolled adrenal insufficiency
renal impairment (GFR <45ml/min)
cardiac failure
symptomatic liver disease / severe hepatic impairment (ALAT / aspartate transaminase (ASAT) > 3x upper limit)
treatment with SGLT 2 inhibitors, lithium chloride, urea or glitazone
severe immunosuppression
pregnancy or breastfeeding
palliative situation (end of life care)
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