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AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring

Diagnostic Accuracy, Usability, Patient Compliance, and System Reliability of the AK+ Guard™ ECG Application for Hyperkalemia Prediction in Ambulatory Chronic Kidney Disease Patients (Outpatient and Remote Monitoring Arms)

Who can join

Ages 22 and older · All sexes

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

About the study

The goal of this observational pilot study is to evaluate the investigational AK+ Guard™ software as a medical device (SaMD) for detection of moderate to severe hyperkalemia (serum potassium (K+) ≥ 6.5 mmol/L) in adults with chronic kidney disease (CKD).

Study objectives are:

* Arm 2A (Outpatient Diagnostic Accuracy): To generate a preliminary, real-world signal of the diagnostic performance of AK+ Guard™ when used in an ambulatory CKD cohort for identifying clinically significant hyperkalemia episodes (serum K+ ≥ 6.5 mmol/L) at the time of an outpatient laboratory draw. * Arm 2B (Remote Patient Monitoring): To assess participant compliance, usability, and end-to-end system reliability of AK+ Guard™ when deployed for daily remote monitoring of CKD patients outside the clinical environment for up to four weeks.

What is being tested

• AK+ Guard™ ECG Application (device)

Sponsor: AccurKardia, Inc. · Participants: 50 · Started: Oct 14, 2025

Contact the study team

• Moin Hussaini · Phone: 718-708-3522

Official record on ClinicalTrials.gov — NCT07210021

Locations in the U.S.

Conditions

• Chronic Kidney Disease

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.