the EMPOWER Study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitaetsspital Basel

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

Trial duration

17 Oct 2025 → ongoing

Decision date (initial)

2025-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-508610-42-00

ClinicalTrials.gov

NCT04447911

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Secondary objectives 4

1. Has an impact on other laboratory parameters (i.e. urine sodium, estimated glomerular filtration rate (eGFR), blood and urine -osmolality, -potassium, -creatinine, -urea, -uric acid, -glucose electrolyte free water clearance, biomarkers of salt-water balance, bone markers)
2. Influences short and long-term course of plasma sodium levels
3. Impact on hyponatremia related clinical outcomes (i.e. thirst and symptoms of hyponatremia (i.e. headache, vertigo and nausea), general well-being, quality of life, neurocognitive functions, gait stability, grip strength, incidence of falls and fractures)
4. Influences clinical course (i.e. treatment escalation, length of hospital stay, readmission)

Conditions and MedDRA coding

Hyponatremia

Regulatory references

Scientific advice from competent authorities

Ethikkommission Nordwest- und Zentralschweiz

Plan to share IPD

Yes

IPD plan description

Study raw anonymized data will be shared exclusively on reasonable request to the sponsor based on the submission in written form of a scientific highly qualitative detailed research proposal.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Adult patients, aged ≥18 years
2. Chronic eu- OR hypervolemic non hyperosmolar (<300 mOsm/kg) hyponatremia (heparin plasma sodium <130mmol/L on day of inclusion)

Exclusion criteria 18

1. Known hypersensitivity or allergy to class of drugs or the investigational product
2. Severe symptomatic hyponatremia in need of treatment with 3% NaCl-solution or in need of intensive/intermediate care treatment at time of inclusion
3. Clinical hypovolemia
4. Severe reduction of eGFR <20 mL/min/1,73 m2 (KDIGO G4 and G5) or end stage renal disease
5. Chronic liver insufficiency with Child Pugh Score ≥10 or decompensated liver cirrhosis (jaundice, hepatorenal syndrome, encephalopathy, bleeding, …)
6. 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
7. Uncontrolled hypothyroidism
8. Uncontrolled adrenal insufficiency
9. Systolic blood pressure <90mmHg
10. Contraindication for lowering blood pressure
11. Diabetes mellitus type 1 or pancreatic diabetes mellitus
12. Treatment with SGLT2 inhibitors, lithium chloride, vaptans, demeclocycline or urea on inclusion day
13. Severe immunosuppression (leucocytes <2 G/l)
14. Peripheral arterial disease stage III-IV of the Fontaine Classification
15. Fasting or other reasons preventing medication intake
16. Participation in another intervention study
17. Pregnancy, breastfeeding, intention to become pregnant during the course of the study or lack of safe contraception
18. End of life care

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. The short-term outcome is the change in average daily area under the curve (AUC) for plasma sodium concentration from baseline (day 0) to day 4.
2. The long-term outcomes is the change in plasma sodium concentration from baseline to day 30

Secondary endpoints 22

1. Short (day 1, day 2, day 3, day of discharge term course of plasma sodium level
2. Urine sodium, eGFR, serum and urine -osmolality, -potassium, -creatinine, -urea, -uric acid, -glucose, -CRP at baseline, on day 4, and day 30
3. Blood and urine aliquots on day 0, day 1, day 4 and day 30, including predefined analysis: markers of salt-water balance (MR-proANP, NT-proBNP, copeptin, aldosteron, renin) and markers of bone metabolism (procollagen type I N propeptide (P1NP) and serum C telopeptide (CTX)
4. Daily fluid intake (mL) from baseline (day 0) to day 4
5. Change in body weight (including AUC 24h – 4 days), blood pressure and heart rate twice a day at baseline (day 0) and on day 1 and then once a day on day 2, day 3, day 4, and day 30
6. Course of thirst and symptoms of hyponatremia assessed on a yes or no basis: headache, vertigo and nausea at baseline (day 0), on day 4 and day 30
7. Course of general well-being rated by patients on a visual analogue scale (VAS) reaching from 0 (no well-being) to 10 (excellent well-being) at baseline (day 0), on day 4 and day 30
8. Change in quality of life assessed by the EQ-5D-5L questionnaire at baseline (day 0), on day 4 and day 30
9. Change in neurocognitive functions assessed by the MoCA Test and the Trail Making Test A and B at baseline (day 0), on day 4 and day 30
10. Change in gait stability assessed by the Timed Up and Go Test at baseline (day 0), on day 4 and day 30
11. Fall as admission (co)-diagnosis at baseline or as re-admission (co)-diagnosis during treatment period (Day 0 – Day 30)
12. Incidence of fractures during the twelve months prior to treatment start, fractures as admission (co)-diagnosis at baseline or as re-admission (co)-diagnosis during treatment period (Day 0 – Day 30)
13. Grip strength measured with a hand dynamometer at baseline (day0), on day 4 and day 30
14. Percentage of patients with plasma sodium concentration that has normalized after 4, on day of discharge) and after 30 days of treatment
15. Duration (days) until normonatremia has been reached
16. Recurrence-rate of hyponatremia during treatment period (Day 0 – Day 30)
17. Recurrence of hyponatremia after treatment completion according to plasma sodium measurement at follow up (day 37 +21/- 3 days)
18. Need for additional hyponatremia treatment and treatment escalation (e.g. administration of 3% NaCl infusion) during treatment period (Day 0 – Day 30)
19. Rate of ICU-admissions during treatment period (Day 0 – Day 30)
20. Length of hospital stay (days)
21. Rate of readmission due to hyponatremia and other causes during treatment period (Day 0 – Day 30)
22. Baseline characteristics including age, gender, medical history, medication, date of hospitalisation and admission diagnosis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitaetsspital Basel

Sponsor organisation

Universitaetsspital Basel

Address

Petersgraben 4

City

Basel Town

Postcode

4031

Country

Switzerland

Scientific contact point

Organisation

Universitaetsspital Basel

Contact name

Prof. Mirjam Christ-Crain

Public contact point

Organisation

Universitaetsspital Basel

Contact name

Prof. Mirjam Christ-Crain

Locations

2 EU/EEA countries · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 11 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications