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Effects of the SGLT2 Inhibitor Empagliflozin in Patients With Euvolemic and Hypervolemic Hyponatremia

Study acronym: EMPOWER
StatusCompleted
PhasePhase 4
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 2 entries Show 4 more changesShow less
    • Trial completed
    • Primary and study completion dates changed from estimate of Sep 15, 2026 to Sep 17, 2026
    • Eligibility criteria expanded, about 19 words
    • Site details revised at 6 of 6 sites
  2. Notable Enrollment reduced: 172 → 113 participants
    • Primary completion moved earlier from Jan 2027 to Sep 15, 2026
    • Study completion moved earlier from Feb 2027 to Sep 15, 2026
    • Site details revised at 1 of 6 sites
    v10
  3. Notable Primary completion date: Jan 2026 to Jan 2027
    • Study sites: 3 to 6
    • Study completion date: Feb 2026 to Feb 2027
    v9
  4. Notable Primary completion date: Jan 2025 to Jan 2026
    • Study completion date: Feb 2025 to Feb 2026
    v8
  5. Notable Primary completion date: Jan 2023 to Jan 2025
    • Study completion date: Feb 2023 to Feb 2025
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Notable Primary endpoints: 1 to 2
    • Eligibility criteria revised
    v6
  2. Minor Site details revised at 1 of 3 sites
    • Collaborators: 1 to 2
    v5
  3. Minor Study sites: 1 to 3
    • Eligibility criteria expanded, about 4 words
    v4
  4. Minor Eligibility criteria expanded, about 18 words
    • Site contact updated
    • Collaborators expanded, about 2 words
    v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2021 to Feb 4, 2021
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04447911
Lead Sponsor University Hospital, Basel, Switzerland
Collaborators: Luzerner Kantonsspital, Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)
Hyponatremia, SIADH, Liver Failure, Kidney Failure
Related terms Hyponatremia, Inappropriate ADH Syndrome, Liver Failure, Renal Insufficiency
Enrollment 113 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov