Study on the Effects of Empagliflozin in Patients with Euvolemic and Hypervolemic Hyponatremia

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What is this study about?

This clinical trial is focused on studying a condition called hyponatremia, which occurs when there is a low level of sodium in the blood. The study will explore the effects of a medication called empagliflozin, also known by its brand name Jardiance. Empagliflozin is a type of drug known as an SGLT2 inhibitor, which is typically used to help control blood sugar levels in people with diabetes. In this study, it will be used to see if it can help increase sodium levels in patients with hyponatremia.

The purpose of the study is to determine if taking empagliflozin once daily can lead to a greater increase in blood sodium levels over a short period of 4 days and a longer period of 30 days, compared to a placebo. Participants in the study will be randomly assigned to receive either empagliflozin or a placebo. The study will be conducted in a double-blind manner, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will have their sodium levels monitored regularly. They will also be assessed for changes in their overall well-being, quality of life, and any symptoms related to hyponatremia, such as headache, dizziness, and nausea. The study will also track other health indicators, including blood pressure, heart rate, and body weight. The trial aims to provide valuable insights into whether empagliflozin can be an effective treatment for improving sodium levels in patients with hyponatremia.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The study aims to investigate the effect of the medication empagliflozin on patients with a condition called hyponatremia, which is a low level of sodium in the blood.

2 medication administration

The patient will receive a medication called Jardiance, which contains empagliflozin. The dosage is 25 mg, taken as a film-coated tablet once daily by mouth. This will continue from the start of the study (day 0) to day 30.

3 initial assessments

On day 0, the patient will undergo various assessments to establish baseline measurements. These include blood and urine tests to measure sodium levels and other health markers, as well as evaluations of general well-being, quality of life, and cognitive functions.

4 daily monitoring

From day 0 to day 4, the patient will have daily monitoring of fluid intake, body weight, blood pressure, and heart rate. Symptoms such as headache, dizziness, and nausea will be assessed, along with overall well-being.

5 follow-up assessments

On day 4 and day 30, the patient will repeat the assessments conducted on day 0. This includes blood and urine tests, evaluations of well-being, quality of life, cognitive functions, and physical stability.

6 end of treatment period

On day 30, the treatment period ends. The patient will have a final set of assessments to measure changes in sodium levels and other health markers. The study will also evaluate the need for any additional treatment for hyponatremia.

7 post-treatment follow-up

After the treatment period, a follow-up will occur around day 37 to check for any recurrence of hyponatremia and to assess the patient’s overall health status.

Who Can Join the Study?

Must be an adult aged 18 years or older.
Must have a condition called chronic euvolemic or hypervolemic hyponatremia. This means having low sodium levels in the blood, but not due to dehydration or high blood sugar levels.
Sodium levels in the blood must be less than 135 mmol/L on the day of joining the study.
Both men and women can participate.
Participants should not belong to a vulnerable population, which means they should be able to make decisions for themselves and not be in a situation where they are easily influenced or at risk.

Who Cannot Join the Study?

Patients with hyponatremia cannot participate. Hyponatremia is a condition where there is a low level of sodium in the blood.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Eolxbet Uchdhbxfnomk Mskutup Cpmvbsg Rxibjvyik (plhujzs Mgy	Rotterdam	The Netherlands
Uyqegzcervvyytbozvhzn Whlvtqwmb Anq	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not yet recruiting	17.02.2025
The Netherlands	Recruiting	17.02.2025

Trial locations

Investigated drugs:

Empagliflozin is a medication used in this clinical trial to help manage sodium levels in the blood. It works by helping the kidneys remove excess sugar from the body through urine, which can also lead to changes in fluid balance and sodium levels. In this study, the researchers are investigating whether taking empagliflozin can help increase the sodium concentration in the blood of patients who have low sodium levels due to conditions where the body holds onto too much water. The goal is to see if empagliflozin can help correct this imbalance more effectively than not taking the medication.

Hyponatremia – Hyponatremia is a condition characterized by low levels of sodium in the blood. Sodium is essential for maintaining fluid balance, nerve function, and muscle function. In hyponatremia, the imbalance can lead to symptoms such as headache, nausea, and confusion. The condition can progress to more severe symptoms like muscle cramps, seizures, and decreased consciousness if sodium levels continue to drop. It can occur due to various factors, including excessive fluid intake, certain medications, or underlying health conditions affecting the kidneys or hormones. The progression and severity of symptoms depend on how quickly the sodium levels decrease and the underlying cause.

Trial ID:

2023-508610-42-00

Protocol code:

EKNZ-2020-01917

NCT ID:

NCT04447911

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Empagliflozin in Patients with Euvolemic and Hypervolemic Hyponatremia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?