Ignite Creation Date:
2024-05-06 @ 2:52 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447911
Status:
RECRUITING
Last Update Posted:
2023-06-01
First Post:
2020-06-10
Brief Title:
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia
Sponsor:
University Hospital Basel Switzerland
Organization:
University Hospital Basel Switzerland
Study Overview
Official Title:
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial the EMPOWER Study
Status:
RECRUITING
Status Verified Date:
2023-05
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:
EMPOWER
Brief 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 ie 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
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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None