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

Conditions

• Hyponatremia
• SIAD - Syndrome of Inappropriate Antidiuresis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Empagliflozin 25mg — DRUG
  Treatment with empagliflozin 25mg once daily for 28 days
• Placebo — DRUG
  Treatment with Placebo oral tablet once daily for 28 days

Study Details

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.

Key Dates

Start date

Dec 15, 2017

Status verified

Dec 2021

Primary completion

Aug 26, 2021

Completion

Dec 6, 2021

Study Design

Enrollment

17 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Active Comparator: Empagliflozin
  Treatment with empagliflozin 25mg tablets once daily for 28 days
• Placebo Comparator: Placebo
  Treatment with Placebo tablets once daily for 28 days

Primary Outcome Measure

Change in Serum Sodium concentration [ Time Frame: 28 days ]