Actively Recruiting
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia - a Multicentric Randomized Double-blind Placebo-controlled Trial (the EMPOWER Study)
Led by University Hospital, Basel, Switzerland · Updated on 2025-11-17
172
Participants Needed
6
Research Sites
4 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
L
Luzerner Kantonsspital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hyponatremia, a common electrolyte imbalance in hospitalized patients, is classified into hypovolemic, euvolemic, or hypervolemic types. The syndrome of inappropriate antidiuresis (SIAD) often causes euvolemic hyponatremia, while congestive heart failure and liver cirrhosis are common causes of hypervolemic hyponatremia. Current treatments, including fluid restriction, have limited effectiveness. Researchers are evaluating the SGLT2 inhibitor empagliflozin (Jardiance) for its potential to increase serum sodium levels in these conditions through a randomized, placebo-controlled trial. Participants will receive either empagliflozin 25 mg or a placebo once daily by mouth for 30 days. The study is double-blind and randomized, comparing empagliflozin's effects without additional fluid restriction. The trial aims to assess the impact of the drug on serum sodium concentration and other related measures over both short-term (4 days) and longer-term (30 days) periods. During the study, participants will undergo regular assessments including measurements of serum sodium, body weight, blood pressure, plasma and urinary markers, and various health and well-being indicators such as cognitive function, quality of life, and occurrence of symptoms like thirst or headache. Safety and clinical outcomes like hospital stay length will also be monitored. The total participation duration is 30 days, with detailed monitoring throughout this period.
CONDITIONS
Brief Title
Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chronic euvolemic or hypervolemic non-hyperosmolar hyponatremia with plasma sodium below 135 mmol/L on day of inclusion
You will not qualify if you...
- Known allergy or hypersensitivity to the study drug or its class
- Severe symptomatic hyponatremia needing 3% NaCl treatment or intensive care at inclusion
- Clinical hypovolemia
- Severe kidney impairment with eGFR below 20 mL/min/1.73 m2 or end stage renal disease
- Chronic liver failure with Child Pugh Score 10 or higher or decompensated liver cirrhosis
- Liver enzymes AST or ALT more than 3 times upper normal limit or bilirubin more than twice upper normal limit at enrolment
- Uncontrolled hypothyroidism
- Uncontrolled adrenal insufficiency
- Systolic blood pressure under 90 mmHg
- Contraindication for lowering blood pressure
- Type 1 diabetes or pancreatic diabetes
- Treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day
- Severe immunosuppression with low white blood cells (below 2 G/l)
- Peripheral arterial disease stage III-IV
- Fasting or inability to take medication
- Previous participation in this study
- Participation in another intervention study
- Pregnancy, breastfeeding, planning pregnancy, or no safe contraception
- End of life care
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 30 days
Participants take Empagliflozin or placebo once daily as part of their treatment for hyponatremia.
1 baseline visit and multiple follow-up visits during treatment
Trial Site Locations
Total: 6 locations
1
University Hospital of Würzburg, med. Poliklinik
Würzburg, Germany, 97080
Actively Recruiting
2
Erasmus Universität Medisch Centrum Rotterdam, Department of Internal Medicine
Rotterdam, Netherlands, 3015
Actively Recruiting
3
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
4
University Hospital Basel
Basel, Switzerland, 4031
Actively Recruiting
5
Spitalzentrum Biel
Biel, Switzerland, 2502
Actively Recruiting
6
Kantonsspital Luzern
Lucerne, Switzerland, 6000
Actively Recruiting
Research Team
M
Mirjam Christ-Crain, Prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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