Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02874807
Status:
COMPLETED
Last Update Posted:
2019-06-13
First Post:
2016-08-17
Brief Title:
Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAND
Brief 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
The therapeutic options aside from treating the underlying disease depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion Alternative therapeutic options are loop diuretics administration of oral urea or vasopressin receptor antagonists vaptans Despite those options there are a considerable number of patients which do not sufficiently respond making additional therapy necessary
Empagliflozin Jardiance is a sodium glucose co-transporter 2 SGLT2-inhibitor which is a new treatment option developed for patients with diabetes mellitus type 2 The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH
The aim of this study is to evaluate whether empagliflozin Jardiance has an effect on the serum sodium levels of patients with SIADH
The therapeutic options aside from treating the underlying disease depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion Alternative therapeutic options are loop diuretics administration of oral urea or vasopressin receptor antagonists vaptans Despite those options there are a considerable number of patients which do not sufficiently respond making additional therapy necessary
Empagliflozin Jardiance is a sodium glucose co-transporter 2 SGLT2-inhibitor which is a new treatment option developed for patients with diabetes mellitus type 2 The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH
The aim of this study is to evaluate whether empagliflozin Jardiance has an effect on the serum sodium levels of patients with SIADH
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None