Effects of Empagliflozin on Hyponatremia in Patients
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)
This study is testing if the medication Empagliflozin can help people with low sodium levels in their blood feel better by balancing their sodium and reducing extra fluid.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 172 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 6 sites (Würzburg and 5 other locations) |
| Trial ID | NCT04447911 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of the SGLT2 inhibitor Empagliflozin on patients suffering from euvolemic and hypervolemic hyponatremia, conditions characterized by low sodium levels in the blood. The study aims to evaluate the efficacy of Empagliflozin in promoting sodium balance and reducing fluid retention, which are common issues in patients with conditions like SIADH, liver failure, and kidney failure. Participants will receive either Empagliflozin or a placebo to assess the drug's impact on sodium levels and overall fluid management. The trial is designed to provide insights into a potentially new treatment approach for these challenging electrolyte imbalances.
Who should consider this trial
Good fit: Ideal candidates include individuals with chronic euvolemic or hypervolemic hyponatremia and low plasma sodium levels.
Not a fit: Patients with severe symptomatic hyponatremia requiring immediate treatment or those with significant renal or liver impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients with difficult-to-manage hyponatremia.
How similar studies have performed: While the use of SGLT2 inhibitors is well-established for diabetes management, their application in treating hyponatremia is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- chronic eu- OR hypervolemic non hyperosmolar (\<300 mOsm/kg) hyponatremia (heparin plasma sodium \<135 mmol/L on day of inclusion) Exclusion Criteria: * known hypersensitivity or allergy to class of drugs or the investigational product, * 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 * 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 * previous enrolment into the current study * 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
Where this trial is running
Würzburg and 5 other locations
- University Hospital of Würzburg, med. Poliklinik — Würzburg, Germany (Recruiting)
- Erasmus Universität Medisch Centrum Rotterdam, Department of Internal Medicine — Rotterdam, Netherlands (Recruiting)
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland (Recruiting)
- University Hospital Basel — Basel, Switzerland (Recruiting)
- Spitalzentrum Biel — Biel, Switzerland (Recruiting)
- Kantonsspital Luzern — Lucerne, Switzerland (Recruiting)
Study contacts
- Principal investigator: Julie Refardt, MD — University Hospital, Basel, Switzerland
- Study coordinator: Mirjam Christ-Crain, Prof
- Email: Mirjam.Christ-Crain@usb.ch
- Phone: +41 61 328 70 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.