A Phase 4 interventional study of Empagliflozin 25 MG and Placebo in Hyponatremia, SIADH and Liver Failure, sponsored by University Hospital, Basel, Switzerland. Completed at 6 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by University Hospital, Basel, Switzerland · Phase 4, Interventional, and Treatment
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.
164 studies on the registry are indexed under Hyponatremia; 16 are open to participants now.
This study's enrollment of 113 is above the median of 60 across 98 interventional studies indexed under Hyponatremia.
Browse Hyponatremia studies →University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.
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- chronic eu- OR hypervolemic non hyperosmolar (\<300 mOsm/kg) hyponatremia (heparin plasma sodium \<135 mmol/L on day of inclusion)
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Empagliflozin (Jardiance)® 25mg per os once daily for 30 days
Drug: Empagliflozin 25 MG
Placebo (Lactose tablet) per os once daily for 30 days
Drug: Placebo
Empagliflozin 25mg per os once daily for 30 days
Placebo per os once daily for 30 days
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
Long-term serum sodium change (before/after treatment)
Absolute change in serum sodium concentration from baseline to end of treatment
Time frame: 30 days
Impact intervention on bodyweight
change of bodyweight
Time frame: 30 days
Impact intervention on blood pressure
change of blood pressure
Time frame: 30 days
Course of serum sodium level
Course of serum sodium level
Time frame: 30 days
Change of plasma osmolality
Change of plasma osmolality
Time frame: 30 days
Change of urinary osmolality
Change of urinary osmolality
Time frame: 30 days
Change of plasma urea
Change of plasma urea
Time frame: 30 days
Change of urinary urea
Change of urinary urea
Time frame: 30 days
Change of plasma uric acid
Change of plasma uric acid
Time frame: 30 days
Change of urinary uric acid
Change of urinary uric acid
Time frame: 30 days
Change of plasma creatinin
Change of plasma creatinin
Time frame: 30 days
Change of urinary creatinin
Change of urinary creatinin
Time frame: 30 days
Change of plasma potassium
Change of plasma potassium
Time frame: 30 days
Change of urinary potassium
Change of urinary potassium
Time frame: 30 days
Change in plasma copeptin
Change in plasma copeptin
Time frame: 30 days
Change in plasma aldosterone
Change in plasma aldosterone
Time frame: 30 days
Change in plasma renin
Change in plasma renin
Time frame: 30 days
Change in plasma MR-proANP
Change in plasma MR-proANP
Time frame: 30 days
Change in plasma NT-proBNP
Change in plasma NT-proBNP
Time frame: 30 days
Change in plasma CTX
Change in plasma CTX
Time frame: 30 days
Change in plasma P1NP
Change in plasma P1NP
Time frame: 30 days
Occurence of thirst
Occurence of thirst
Time frame: 30 days
Occurence of headache
Occurence of headache
Time frame: 30 days
Occurence of vertigo
Occurence of vertigo
Time frame: 30 days
Occurence of nausea
Occurence of nausea
Time frame: 30 days
Change in general well-being
Change in general well-being according to visual analogue scale
Time frame: 30 days
Change in quality of life
change in quality of life according to EQ-5D-5L questionnaire
Time frame: 30 days
Change in cognitive impairment
Change in cognitive impairment measured with the MoCa test
Time frame: 30 days
Change in visual attention
Change in visual attention measured with the trail making test
Time frame: 30 days
Change in neuromuscular impairment
Change in neuromuscular impairment measured with the timed up and go test
Time frame: 30 days
Change in grip strength
Change in grip strength measured with a hand dynamometer
Time frame: 30 days
Occurence of falls
Occurence of falls
Time frame: 30 days
Occurence of fractures
Occurence of fractures
Time frame: 30 days
Length of hospital stay
Length of hospital stay
Time frame: 30 days
Plan to share: Yes
No publications or documents are linked to this record.
Ran from Feb 2021 to primary completion in Sep 2026, 67 months.
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This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Empagliflozin
University Hospital, Basel, Switzerland →