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. Especially chronic (\>72h) SIADH is difficult to treat as standard therapeutic options (water restriction, urea, salt tablets) often do not succeed in correction of hyponatremia, making additional therapy necessary. Empagliflozin is a sodium glucose co-transporter 2 (SGLT2)-inhibitor, which is a well-tolerated treatment option for type 2 diabetes mellitus. The inhibition of SGLT2 in the proximal tubule leads to renal excretion of glucose with subsequent osmotic diuresis. This mechanism could result in a therapeutic effect in patients with chronic SIADH, as it resembles the aquaretic effect of urea. The aim of this study is to evaluate whether empagliflozin has an effect on the serum sodium levels of patients with chronic SIADH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Treatment with empagliflozin 25mg once daily for 28 days
Treatment with Placebo oral tablet once daily for 28 days
University Hospital Basel
Basel, Switzerland
Change in Serum Sodium concentration
Difference in serum sodium concentration in mmol/l after 28 days of treatment
Time frame: 28 days
Change in Serum sodium concentration
Serum sodium concentration 1, 2 and 3 weeks of treatment
Time frame: 21 days
Change in Serum electrolytes
Serum electrolytes after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Urinary electrolytes
Urinary electrolytes after 1 week of treatment
Time frame: 7 days
Urinary electrolytes
Urinary electrolytes after 2 weeks of treatment
Time frame: 14 days
Urinary electrolytes
Urinary electrolytes after 3 weeks of treatment
Time frame: 21 days
Urinary electrolytes
Urinary electrolytes after 4 weeks of treatment
Time frame: 28 days
Serum osmolality
Serum osmolality after 1 week of treatment
Time frame: 7 days
Serum osmolality
Serum osmolality after 2 weeks of treatment
Time frame: 14 days
Serum osmolality
Serum osmolality after 3 weeks of treatment
Time frame: 21 days
Serum osmolality
Serum osmolality after 4 weeks of treatment
Time frame: 28 days
Urinary osmolality
Urinary osmolality after 1 week of treatment
Time frame: 7 days
Urinary osmolality
Urinary osmolality after 2 weeks of treatment
Time frame: 14 days
Urinary osmolality
Urinary osmolality after3 weeks of treatment
Time frame: 21 days
Urinary osmolality
Urinary osmolality after 4 weeks of treatment
Time frame: 28 days
Serum glucose
Serum glucose after 1 week of treatment
Time frame: 7 days
Serum glucose
Serum glucose after 2 weeks of treatment
Time frame: 14 days
Serum glucose
Serum glucose after 3 weeks of treatment
Time frame: 21 days
Serum glucose
Serum glucose after 4 weeks of treatment
Time frame: 28 days
Urinary glucose
Urinary glucose after 1 week of treatment
Time frame: 7 days
Urinary glucose
Urinary glucose after 2 weeks of treatment
Time frame: 14 days
Urinary glucose
Urinary glucose after 3 weeks of treatment
Time frame: 21 days
Urinary glucose
Urinary glucose after 4 weeks of treatment
Time frame: 28 days
Copeptin
Plasma copeptin after 1 week of treatment
Time frame: 7 days
Copeptin
Plasma copeptin after 2 weeks of treatment
Time frame: 14 days
Copeptin
Plasma copeptin after3 weeks of treatment
Time frame: 21 days
Copeptin
Plasma copeptin after 4 weeks of treatment
Time frame: 28 days
Aldosterone
Plasma aldosterone after 1 week of treatment
Time frame: 7 days
Aldosterone
Plasma aldosterone after 2 weeks of treatment
Time frame: 14 days
Aldosterone
Plasma aldosterone after 3 weeks of treatment
Time frame: 21 days
Aldosterone
Plasma aldosterone after 4 weeks of treatment
Time frame: 28 days
Renin
Plasma renin after 1 week of treatment
Time frame: 7 days
Renin
Plasma renin after 2 weeks of treatment
Time frame: 14 days
Renin
Plasma renin after 3 weeks of treatment
Time frame: 21 days
Renin
Plasma renin after 4 weeks of treatment
Time frame: 28 days
MR-proANP
Plasma MR-proANP after 1 week of treatment
Time frame: 7 days
MR-proANP
Plasma MR-proANP after 2 weeks of treatment
Time frame: 14 days
MR-proANP
Plasma MR-proANP after 3 weeks of treatment
Time frame: 21 days
MR-proANP
Plasma MR-proANP after 4 weeks of treatment
Time frame: 28 days
N terminal (NT)-proBNP
Plasma NT-proBNP after 1 week of treatment
Time frame: 7 days
NT-proBNP
Plasma NT-proBNP after 2 weeks of treatment
Time frame: 14 days
NT-proBNP
Plasma NT-proBNP after 3 weeks of treatment
Time frame: 21 days
NT-proBNP
Plasma NT-proBNP after 4 weeks of treatment
Time frame: 28 days
P1NP
Plasma P1NP after 1 week of treatment
Time frame: 7 days
P1NP
Plasma P1NP after 2 weeks of treatment
Time frame: 14 days
P1NP
Plasma P1NP after 3 weeks of treatment
Time frame: 21 days
P1NP
Plasma P1NP after 4 weeks of treatment
Time frame: 28 days
CTx
Plasma CTx after 1 week of treatment
Time frame: 7 days
CTx
Plasma CTx after 2 weeks of treatment
Time frame: 14 days
CTx
Plasma CTx after 3 weeks of treatment
Time frame: 21 days
CTx
Plasma CTx after 4 weeks of treatment
Time frame: 28 days
Osteocalcin
Plasma Osteocalcin after 1 week of treatment
Time frame: 7 days
Osteocalcin
Plasma Osteocalcin after 2 weeks of treatment
Time frame: 14 days
Osteocalcin
Plasma Osteocalcin after 3 weeks of treatment
Time frame: 21 days
Osteocalcin
Plasma Osteocalcin after 4 weeks of treatment
Time frame: 28 days
General well being (assessed by VAS)
General well being after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Headache (assessed by VAS)
Headache after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Vertigo (assessed by VAS)
vertigo after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Nausea (assessed by VAS)
Nausea after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Malaise (assessed by VAS)
Malaise after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Body weight (kg)
Body weight after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Blood pressure (mmHg)
Blood pressure after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Heart rate (bpm)
Heart rate after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Neurocognitive function (assessed by MOCA)
change in Neurocognitive function (baseline versus after 4 weeks of Treatment)
Time frame: 28 days
Muscle strength (measured by grip strength test)
Change in Muscle strength (baseline vs after 4 weeks of Treatment)
Time frame: 28 days
Gait Dynamics (measured by gait Analysis)
Gait dynamics baseline vs after 4 weeks of treatment
Time frame: 28 days
Hemodynamic Parameters (measured by thoracic electrical bioimpedance)
Hemodynamic parameters baseline vs after 4 weeks of treatment
Time frame: 28 days
Body fluid volume (measured by bioimpedance spectroscopy)
Body fluid volume baseline vs after 4 weeks of treatment
Time frame: 28 days
Amount of Fluid intake in ml
Fluid intake after 1, 2, 3 and 4 weeks of treatment
Time frame: 28 days
Number of Falls
Rate of falls during observation phase
Time frame: 30 days
number of Fractures
Rate of fractures during observation phase
Time frame: 30 days
number of Hospital admissions
Rate of Hospital admissions during observation phase
Time frame: 30 days
Hyponatremia recurrence
Rate of hyponatremia recurrence during 30day follow up
Time frame: 30 days
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