BridgeMD
the EMPOWER Study
EU CTIS ID: 2023-508610-42-00
What this study is testing
To investigate whether a treament with empagliflozin (Jardiance)® 25mg once daily results in a stronger average daily increase in plasma sodium concentration from baseline (day 0) to day 4 and from baseline (day 0) to day 30 in patients with euvolemic or hypervolemic hyponatremia compared to placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adult patients, aged ≥18 years
- Chronic eu- OR hypervolemic non hyperosmolar (<300 mOsm/kg) hyponatremia (heparin plasma sodium <130mmol/L on day of inclusion)
You likely can't join if
- Known hypersensitivity or allergy to class of drugs or the investigational product
- Contraindication for lowering blood pressure
- Diabetes mellitus type 1 or pancreatic diabetes mellitus
- Treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day
- Severe immunosuppression (leucocytes <2 G/l)
- Peripheral arterial disease stage III-IV of the Fontaine Classification
See the full eligibility criteria
- Adult patients, aged ≥18 years
- Chronic eu- OR hypervolemic non hyperosmolar (<300 mOsm/kg) hyponatremia (heparin plasma sodium <130mmol/L on day of inclusion)
- Known hypersensitivity or allergy to class of drugs or the investigational product
- Contraindication for lowering blood pressure
- Diabetes mellitus type 1 or pancreatic diabetes mellitus
- Treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day
- Severe immunosuppression (leucocytes <2 G/l)
- Peripheral arterial disease stage III-IV of the Fontaine Classification
- Fasting or other reasons preventing medication intake
- Participation in another intervention study
- Pregnancy, breastfeeding, intention to become pregnant during the course of the study or lack of safe contraception
- End of life care
- Severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive/intermediate care treatment at time of inclusion
- Clinical hypovolemia
- Severe reduction of eGFR <20 mL/min/1,73 m2 (KDIGO G4 and G5) or end stage renal disease
- Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …)
- Hepatic impairment defined as aspartate transaminase (AST) or alanine transaminase (ALT) >3x the upper limit of normal (ULN); or total bilirubin >2x ULN at time of enrolment
- Uncontrolled hypothyroidism
- Uncontrolled adrenal insufficiency
- Systolic blood pressure <90mmHg
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.