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Low sodium levels may disrupt heart rhythms, study finds

NCT ID NCT07255833

Knowledge-focused Sponsor: University of Cologne Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study examined 250 adults with dangerously low sodium levels to see how it changes their heart's electrical signals (ECG). Researchers compared ECGs taken when sodium was low and after it was corrected. The goal was to understand which heart rhythm changes occur and whether they go away after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

250 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with profound hyponatremia presenting to the emergency department

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult patients ≥18 years of the Emergency Department of the University Hospital of Cologne/Germany * Plasma sodium ≤125 mmol/L in the admission blood sample and ≥ 130 mEq/L in a subsequent sample obtained during inpatient care. * 12-lead-ECG on admission and a second ECG during inpatient care after resolution of profound hyponatremia. Exclusion Criteria: * Lack of follow-up sodium analyses within the first 24 hours after admission * initial blood glucose \>300 mg/dL * Moderate or severe hypokalemia (potassium level \< 3 mmol/L) * Moderate or severe hyperkalemia (potassium level \> 6 mmol/L) * Pacemaker dependency with ventricular pacing * Relevant structural heart disease * Severe ischemic cardiomyopathy with an EF \< 35% * Untreated severe aortic valve stenosis * Dilated cardiomyopathy (DCM) * Hypertrophic cardiomyopathy (HCM) * Arrhythmogenic right ventricular cardiomyopathy (ARVC) * Infiltrative cardiomyopathy * Ion channel disease

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Conditions

The condition(s) this trial relates to.

Arrhythmias, Cardiac Hyponatremia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hyponatremia

Contacts and locations

Locations

  • University Hospital Cologne

    Cologne, 50937, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.