Effects of the SGLT2-inhibitor Empagliflozin on Patients With Chronic SIADH - the SANDx Study (SANDx)

December 10, 2021 updated by: University Hospital, Basel, Switzerland

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Empagliflozin
Treatment with empagliflozin 25mg tablets once daily for 28 days
Drug: Empagliflozin 25mg
Treatment with empagliflozin 25mg once daily for 28 days
Placebo Comparator: Placebo
Treatment with Placebo tablets once daily for 28 days
Drug: Placebo
Treatment with Placebo oral tablet once daily for 28 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Serum Sodium concentration
Time Frame: 28 days
Difference in serum sodium concentration in mmol/l after 28 days of treatment
28 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Serum sodium concentration
Time Frame: 21 days
Serum sodium concentration 1, 2 and 3 weeks of treatment
21 days
Change in Serum electrolytes
Time Frame: 28 days
Serum electrolytes after 1, 2, 3 and 4 weeks of treatment
28 days
Urinary electrolytes
Time Frame: 7 days
Urinary electrolytes after 1 week of treatment
7 days
Urinary electrolytes
Time Frame: 14 days
Urinary electrolytes after 2 weeks of treatment
14 days
Urinary electrolytes
Time Frame: 21 days
Urinary electrolytes after 3 weeks of treatment
21 days
Urinary electrolytes
Time Frame: 28 days
Urinary electrolytes after 4 weeks of treatment
28 days
Serum osmolality
Time Frame: 7 days
Serum osmolality after 1 week of treatment
7 days
Serum osmolality
Time Frame: 14 days
Serum osmolality after 2 weeks of treatment
14 days
Serum osmolality
Time Frame: 21 days
Serum osmolality after 3 weeks of treatment
21 days
Serum osmolality
Time Frame: 28 days
Serum osmolality after 4 weeks of treatment
28 days
Urinary osmolality
Time Frame: 7 days
Urinary osmolality after 1 week of treatment
7 days
Urinary osmolality
Time Frame: 14 days
Urinary osmolality after 2 weeks of treatment
14 days
Urinary osmolality
Time Frame: 21 days
Urinary osmolality after3 weeks of treatment
21 days
Urinary osmolality
Time Frame: 28 days
Urinary osmolality after 4 weeks of treatment
28 days
Serum glucose
Time Frame: 7 days
Serum glucose after 1 week of treatment
7 days
Serum glucose
Time Frame: 14 days
Serum glucose after 2 weeks of treatment
14 days
Serum glucose
Time Frame: 21 days
Serum glucose after 3 weeks of treatment
21 days
Serum glucose
Time Frame: 28 days
Serum glucose after 4 weeks of treatment
28 days
Urinary glucose
Time Frame: 7 days
Urinary glucose after 1 week of treatment
7 days
Urinary glucose
Time Frame: 14 days
Urinary glucose after 2 weeks of treatment
14 days
Urinary glucose
Time Frame: 21 days
Urinary glucose after 3 weeks of treatment
21 days
Urinary glucose
Time Frame: 28 days
Urinary glucose after 4 weeks of treatment
28 days
Copeptin
Time Frame: 7 days
Plasma copeptin after 1 week of treatment
7 days
Copeptin
Time Frame: 14 days
Plasma copeptin after 2 weeks of treatment
14 days
Copeptin
Time Frame: 21 days
Plasma copeptin after3 weeks of treatment
21 days
Copeptin
Time Frame: 28 days
Plasma copeptin after 4 weeks of treatment
28 days
Aldosterone
Time Frame: 7 days
Plasma aldosterone after 1 week of treatment
7 days
Aldosterone
Time Frame: 14 days
Plasma aldosterone after 2 weeks of treatment
14 days
Aldosterone
Time Frame: 21 days
Plasma aldosterone after 3 weeks of treatment
21 days
Aldosterone
Time Frame: 28 days
Plasma aldosterone after 4 weeks of treatment
28 days
Renin
Time Frame: 7 days
Plasma renin after 1 week of treatment
7 days
Renin
Time Frame: 14 days
Plasma renin after 2 weeks of treatment
14 days
Renin
Time Frame: 21 days
Plasma renin after 3 weeks of treatment
21 days
Renin
Time Frame: 28 days
Plasma renin after 4 weeks of treatment
28 days
MR-proANP
Time Frame: 7 days
Plasma MR-proANP after 1 week of treatment
7 days
MR-proANP
Time Frame: 14 days
Plasma MR-proANP after 2 weeks of treatment
14 days
MR-proANP
Time Frame: 21 days
Plasma MR-proANP after 3 weeks of treatment
21 days
MR-proANP
Time Frame: 28 days
Plasma MR-proANP after 4 weeks of treatment
28 days
N terminal (NT)-proBNP
Time Frame: 7 days
Plasma NT-proBNP after 1 week of treatment
7 days
NT-proBNP
Time Frame: 14 days
Plasma NT-proBNP after 2 weeks of treatment
14 days
NT-proBNP
Time Frame: 21 days
Plasma NT-proBNP after 3 weeks of treatment
21 days
NT-proBNP
Time Frame: 28 days
Plasma NT-proBNP after 4 weeks of treatment
28 days
P1NP
Time Frame: 7 days
Plasma P1NP after 1 week of treatment
7 days
P1NP
Time Frame: 14 days
Plasma P1NP after 2 weeks of treatment
14 days
P1NP
Time Frame: 21 days
Plasma P1NP after 3 weeks of treatment
21 days
P1NP
Time Frame: 28 days
Plasma P1NP after 4 weeks of treatment
28 days
CTx
Time Frame: 7 days
Plasma CTx after 1 week of treatment
7 days
CTx
Time Frame: 14 days
Plasma CTx after 2 weeks of treatment
14 days
CTx
Time Frame: 21 days
Plasma CTx after 3 weeks of treatment
21 days
CTx
Time Frame: 28 days
Plasma CTx after 4 weeks of treatment
28 days
Osteocalcin
Time Frame: 7 days
Plasma Osteocalcin after 1 week of treatment
7 days
Osteocalcin
Time Frame: 14 days
Plasma Osteocalcin after 2 weeks of treatment
14 days
Osteocalcin
Time Frame: 21 days
Plasma Osteocalcin after 3 weeks of treatment
21 days
Osteocalcin
Time Frame: 28 days
Plasma Osteocalcin after 4 weeks of treatment
28 days
General well being (assessed by VAS)
Time Frame: 28 days
General well being after 1, 2, 3 and 4 weeks of treatment
28 days
Headache (assessed by VAS)
Time Frame: 28 days
Headache after 1, 2, 3 and 4 weeks of treatment
28 days
Vertigo (assessed by VAS)
Time Frame: 28 days
vertigo after 1, 2, 3 and 4 weeks of treatment
28 days
Nausea (assessed by VAS)
Time Frame: 28 days
Nausea after 1, 2, 3 and 4 weeks of treatment
28 days
Malaise (assessed by VAS)
Time Frame: 28 days
Malaise after 1, 2, 3 and 4 weeks of treatment
28 days
Body weight (kg)
Time Frame: 28 days
Body weight after 1, 2, 3 and 4 weeks of treatment
28 days
Blood pressure (mmHg)
Time Frame: 28 days
Blood pressure after 1, 2, 3 and 4 weeks of treatment
28 days
Heart rate (bpm)
Time Frame: 28 days
Heart rate after 1, 2, 3 and 4 weeks of treatment
28 days
Neurocognitive function (assessed by MOCA)
Time Frame: 28 days
change in Neurocognitive function (baseline versus after 4 weeks of Treatment)
28 days
Muscle strength (measured by grip strength test)
Time Frame: 28 days
Change in Muscle strength (baseline vs after 4 weeks of Treatment)
28 days
Gait Dynamics (measured by gait Analysis)
Time Frame: 28 days
Gait dynamics baseline vs after 4 weeks of treatment
28 days
Hemodynamic Parameters (measured by thoracic electrical bioimpedance)
Time Frame: 28 days
Hemodynamic parameters baseline vs after 4 weeks of treatment
28 days
Body fluid volume (measured by bioimpedance spectroscopy)
Time Frame: 28 days
Body fluid volume baseline vs after 4 weeks of treatment
28 days
Amount of Fluid intake in ml
Time Frame: 28 days
Fluid intake after 1, 2, 3 and 4 weeks of treatment
28 days
Number of Falls
Time Frame: 30 days
Rate of falls during observation phase
30 days
number of Fractures
Time Frame: 30 days
Rate of fractures during observation phase
30 days
number of Hospital admissions
Time Frame: 30 days
Rate of Hospital admissions during observation phase
30 days
Hyponatremia recurrence
Time Frame: 30 days
Rate of hyponatremia recurrence during 30day follow up
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mirjam Christ-Crain, Prof. Dr. MD, University Hopsital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 26, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 6, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-00701

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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