Clinical Trial: Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effects of the SGLT2-inhibitor Empagliflozin on Patients With SIADH - the SAND Study

Brief Summary:

Syndrome of inappropriate antidiuresis (SIADH) is characterized by an imbalance of antidiuretic vasopressin (AVP) secretion. The impaired AVP regulation leads to water retention and secondary natriuresis and is a common cause for hyponatremia.

The therapeutic options, aside from treating the underlying disease, depend upon the onset and severity of the symptoms and involve usually fluid restriction or hypertonic saline infusion. Alternative therapeutic options are loop diuretics, administration of oral urea or vasopressin receptor antagonists (vaptans). Despite those options, there are a considerable number of patients which do not sufficiently respond, making additional therapy necessary.

Empagliflozin (Jardiance)® is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a new treatment option developed for patients with diabetes mellitus type 2. The SGLT2 is expressed in the proximal tubule and reabsorbs approximately 90 percent of the filtered glucose. The inhibition of SGLT2 results in renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with hypotonic hyponatremia as in SIADH.

The aim of this study is to evaluate whether empagliflozin (Jardiance)® has an effect on the serum sodium levels of patients with SIADH.


Detailed Summary:
Sponsor: University Hospital, Basel, Switzerland

Current Primary Outcome: Serum sodium [ Time Frame: 4 days ]

The primary outcome is the change in serum sodium concentration from baseline to day 5, i.e. 4 days after start of treatment with study drug


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Serum sodium [ Time Frame: 1 day ]
    Serum sodium concentration 1 day after start of Treatment with study drug
  • Serum sodium [ Time Frame: 2 days ]
    Serum sodium concentration 2 days after start of treatment with study drug
  • Serum sodium [ Time Frame: between day 1 to day 30 ]
    Serum sodium concentration at discharge from hospital
  • Serum sodium [ Time Frame: 30 days ]
    Serum sodium concentration 30 days after start of treatment with study drug
  • Fluid intake [ Time Frame: 4 days ]
    amount of daily fluid intake
  • Urinary excretion [ Time Frame: 4 days ]
    amount of daily urinary excretion
  • Serum electrolytes [ Time Frame: 4 days ]
    change of serum electrolytes from baseline to day 5
  • Urinary electrolytes [ Time Frame: 4 days ]
    Change of Serum electrolytes from baseline to day 5
  • Serum osmolality [ Time Frame: 4 days ]
    Change of Serum osmolality from baseline to day 5
  • Urine osmolality [ Time Frame: 4 days ]
    Change of urinary osmolality from baseline to day 5
  • Serum glucose [ Time Frame: 4 days ]
    Change of Serum glucose from baseline to day 5
  • Urinary glucose [ Time Frame: 4 days ]
    Change of urinary Glucose from baseline to day 5
  • Copeptin [ Time Frame: 4 days ]
    Change of Copeptin from baseline to day 5
  • Aldosterone [ Time Frame: 4 days ]
    Change of Aldosterone from baseline to day 5
  • Renin [ Time Frame: 4 days ]
    Change of Renin from baseline to day 5
  • atrial natriuretic peptide (ANP) [ Time Frame: 4 days ]
    Change of ANP from baseline to day 5
  • Brain-Natriuretic-Peptide (BNP) [ Time Frame: 4 days ]
    Change of BNP from baseline to day 5
  • General well-being [ Time Frame: 4 days ]
    course of General well-being from baseline to day 5 as assessed by patient's self-rating score
  • General well-being [ Time Frame: 30 days ]
    course of General well-being from baseline to day 30 as assessed by patient's self-rating score
  • Symptoms of hyponatremia [ Time Frame: 4 days ]
    course of hyponatremia symptoms from baseline to day 5
  • Symptoms of hyponatremia [ Time Frame: 30 days ]
    Course of hyponatremia symptoms from baseline to day 30
  • Body weight [ Time Frame: 4 days ]
    Change of Body weight from baseline to day 5
  • Blood pressure [ Time Frame: 4 days ]
    Change of blood pressure from baseline to day 5
  • Heart rate [ Time Frame: 4 days ]
    Change of heart rate from baseline to day 5
  • length of hospital stay [ Time Frame: 30 days ]
    length of hospital stay
  • Treatment escalation [ Time Frame: 30 days ]
    rate of Need for Treatment escalation
  • ICU Admission rate [ Time Frame: 30 days ]
    rate of Admission to ICU
  • Recurrence hyponatremia [ Time Frame: 30 days ]
    recurrence rate hyponatremia
  • Hospital readmission rate [ Time Frame: 30 days ]
    rate of readmission


Original Secondary Outcome:

  • Serum sodium [ Time Frame: 1 day ]
    Serum sodium concentration 1 day after start of Treatment with study drug
  • Serum sodium [ Time Frame: 2 days ]
    Serum sodium concentration 2 days after start of treatment with study drug
  • Serum sodium [ Time Frame: between day 1 to day 30 ]
    Serum sodium concentration at discharge from hospital
  • Serum sodium [ Time Frame: 30 days ]
    Serum sodium concentration 30 days after start of treatment with study drug
  • Fluid intake [ Time Frame: 4 days ]
    amount of daily fluid intake
  • Urinary excretion [ Time Frame: 4 days ]
    amount of daily urinary excretion
  • Serum electrolytes [ Time Frame: 4 days ]
    change of serum electrolytes from baseline to day 5
  • Urinary electrolytes [ Time Frame: 4 days ]
    Change of Serum electrolytes from baseline to day 5
  • Serum osmolality [ Time Frame: 4 days ]
    Change of Serum osmolality from baseline to day 5
  • Urine osmolality [ Time Frame: 4 days ]
    Change of urinary osmolality from baseline to day 5
  • Serum glucose [ Time Frame: 4 days ]
    Change of Serum glucose from baseline to day 5
  • Urinary glucose [ Time Frame: 4 days ]
    Change of urinary Glucose from baseline to day 5
  • Copeptin [ Time Frame: 4 days ]
    Change of Copeptin from baseline to day 5
  • Aldosterone [ Time Frame: 4 days ]
    Change of Aldosterone from baseline to day 5
  • Renin [ Time Frame: 4 days ]
    Change of Renin from baseline to day 5
  • atrial natriuretic peptide (ANP) [ Time Frame: 4 days ]
    Change of ANP from baseline to day 5
  • Brain-Natriuretic-Peptide (BNP) [ Time Frame: 4 days ]
    Change of BNP from baseline to day 5
  • General well-being [ Time Frame: 4 days ]
    course of General well-being from baseline to day 5 as assessed by patient's self-rating score
  • General well-being [ Time Frame: 30 days ]
    course of General well-being from baseline to day 30 as assessed by patient's self-rating score
  • Symptoms of hyponatremia [ Time Frame: 4 days ]
    course of hyponatremia symptoms from baseline to day 5
  • Symptoms of hyponatremia [ Time Frame: 30 days ]
    Course of hyponatremia symptoms from baseline to day 30
  • Body weight [ Time Frame: 4 days ]
    Change of Body weight from baseline to day 5
  • Blood pressure [ Time Frame: 4 days ]
    Change of blood pressure from baseline to day 5
  • Heart rate [ Time Frame: 4 days ]
    Change of heart rate from baseline to day 5
  • lenght of hospital stay [ Time Frame: 30 days ]
    lenght of hospital stay
  • Treatment escalation [ Time Frame: 30 days ]
    rate of Need for Treatment escalation
  • ICU Admission rate [ Time Frame: 30 days ]
    rate of Admission to ICU
  • Recurrence hyponatremia [ Time Frame: 30 days ]
    recurrence rate hyponatremia
  • Hospital readmission rate [ Time Frame: 30 days ]
    rate of readmission


Information By: University Hospital, Basel, Switzerland

Dates:
Date Received: August 17, 2016
Date Started: August 2016
Date Completion: August 2017
Last Updated: August 22, 2016
Last Verified: August 2016