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Smartphone ECG app could spot dangerous potassium levels in kidney patients

NCT ID NCT07210021

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a smartphone app that uses ECG readings to detect dangerously high potassium levels in people with chronic kidney disease. About 50 adults will use the app during clinic visits or at home for up to four weeks. The goal is to see how accurate, easy-to-use, and reliable the app is for catching this serious condition early.

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

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Nov 2025

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Participants will be adults aged 22 years or older with chronic kidney disease (CKD) stages III-IV who receive care at Central Jersey Kidney Care, an outpatient nephrology clinic. Eligible participants for Arm 2A will be identified at the time of a routine outpatient potassium blood draw. A subset of participants who complete Arm 2A will be invited to enroll in Arm 2B, which involves daily remote monitoring at home for up to four weeks. Participants must have an iPhone compatible with the study application to join Arm 2B.

Ages

22 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: (Arm 2A - Outpatient Diagnostic Accuracy) * Age 22 years or older * CKD stages III-IV managed at Central Jersey Kidney Care outpatient clinic * Scheduled outpatient serum potassium laboratory test * On RAASi therapy or documented hyperkalemia (K+ ≥ 5.5 mmol/L) within the past 12 months * Able to provide written informed consent (Arm 2B - Remote Patient Monitoring) * Completion of Arm 2A visit * Owns an iPhone compatible with the study application Exclusion Criteria (Both arms): * Age 21 years or younger * Pacemaker or implantable cardioverter defibrillator * Pre existing Left Bundle Branch Block (LBBB), Right Bundle Branch Block (RBBB), Intraventricular Conduction Delay (IVCD), or clinically significant hypocalcemia * Potassium lowering treatment administered before Lead I ECG acquisition * Trauma, acute events, or active interventions altering potassium homeostasis * Physical limitation precluding ECG acquisition

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Central Jersey Kidney Care - Hypertension & Nephrology Associates

    RECRUITING

    Eatontown, New Jersey, 07724, United States

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