Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Change in Serum Sodium concentration
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years) with hyponatremia (<133mmol/l) due to chronic (>72h) SIADH defined as
- •serum osmolality <275mosm/kg
- •urine osmolality >100mosm/kg
- •urine sodium >30mmol/l
排除标准
- •acute (<72h) or transient hyponatremia
- •severe symptomatic hyponatremia in need of hospital treatment
- •diabetes mellitus type 1
- •uncontrolled hypothyroidism
- •uncontrolled adrenal insufficiency
- •renal impairment (GFR <45ml/min)
- •cardiac failure
- •symptomatic liver disease / severe hepatic impairment (ALAT / aspartate transaminase (ASAT) > 3x upper limit)
- •treatment with SGLT 2 inhibitors, lithium chloride, urea or glitazone
- •severe immunosuppression
- •pregnancy or breastfeeding
- •palliative situation (end of life care)
研究组 & 干预措施
Empagliflozin
Treatment with empagliflozin 25mg tablets once daily for 28 days
干预措施: Empagliflozin 25mg (Drug)
Placebo
Treatment with Placebo tablets once daily for 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Serum Sodium concentration
时间窗: 28 days
Difference in serum sodium concentration in mmol/l after 28 days of treatment
次要结局
- Change in Serum sodium concentration(21 days)
- Urinary electrolytes(28 days)
- Serum osmolality(28 days)
- Nausea (assessed by VAS)(28 days)
- Change in Serum electrolytes(28 days)
- Urinary osmolality(28 days)
- Serum glucose(28 days)
- Urinary glucose(28 days)
- Copeptin(28 days)
- Aldosterone(28 days)
- Renin(28 days)
- NT-proBNP(28 days)
- Neurocognitive function (assessed by MOCA)(28 days)
- Muscle strength (measured by grip strength test)(28 days)
- Body fluid volume (measured by bioimpedance spectroscopy)(28 days)
- Amount of Fluid intake in ml(28 days)
- Number of Falls(30 days)
- number of Hospital admissions(30 days)
- MR-proANP(28 days)
- N terminal (NT)-proBNP(7 days)
- P1NP(28 days)
- CTx(28 days)
- Osteocalcin(28 days)
- General well being (assessed by VAS)(28 days)
- Malaise (assessed by VAS)(28 days)
- number of Fractures(30 days)
- Headache (assessed by VAS)(28 days)
- Vertigo (assessed by VAS)(28 days)
- Body weight (kg)(28 days)
- Blood pressure (mmHg)(28 days)
- Heart rate (bpm)(28 days)
- Gait Dynamics (measured by gait Analysis)(28 days)
- Hemodynamic Parameters (measured by thoracic electrical bioimpedance)(28 days)
- Hyponatremia recurrence(30 days)