AK+ Guard™ for detecting high potassium in chronic kidney disease: outpatient checks and home 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)

This project will try AK+ Guard™, an app that analyzes a single‑lead (Lead I) ECG, to see if it can detect dangerous high potassium (K+ ≥ 6.5 mmol/L) in adults with stage 3–4 chronic kidney disease.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: AccurKardia, Inc. (industry)
• Locations: 1 site (Eatontown, New Jersey)
• Trial ID: NCT07210021 on ClinicalTrials.gov

What this trial studies

This observational pilot enrolls adults with stage 3–4 CKD to generate preliminary real‑world data on AK+ Guard™, a software that analyzes Lead I ECG signals for moderate to severe hyperkalemia. In Arm 2A the app's outputs at the time of scheduled outpatient lab draws will be compared to serum potassium (K+ ≥ 6.5 mmol/L) to estimate diagnostic accuracy and test interoperability across devices (Apple Watch, HeartBeam, and 12‑lead reference). In Arm 2B participants who complete Arm 2A will be asked to use the app daily for up to four weeks to measure compliance, usability, and end‑to‑end system reliability. The study collects device upload success, algorithm runtime, and standard diagnostic metrics (sensitivity, specificity, PPV, NPV) to characterize performance outside the clinic.

Who should consider this trial

Good fit: Adults aged 22 or older with stage 3–4 CKD managed at the Central Jersey Kidney Care clinic who are on RAAS inhibitors or have prior hyperkalemia and who can consent (and for remote monitoring, own a compatible iPhone) would be ideal candidates.

Not a fit: Patients with pacemakers, bundle branch blocks or other specified conduction abnormalities, clinically significant hypocalcemia, recent potassium‑altering treatments or acute events, or those unable to obtain Lead I ECGs are unlikely to benefit.

Why it matters

Potential benefit: If successful, the app could provide an early, noninvasive warning of dangerous high potassium in at‑risk CKD patients, enabling faster clinical follow‑up.

How similar studies have performed: Prior AI‑based ECG research has shown promising ability to flag hyperkalemia in inpatient settings, but Lead I‑only outpatient and remote detection is relatively novel and less validated.

Eligibility criteria

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

Where this trial is running

Eatontown, New Jersey

• Central Jersey Kidney Care - Hypertension & Nephrology Associates — Eatontown, New Jersey, United States (RECRUITING)

Study contacts

• Study coordinator: Moin Hussaini

Conditions: Hyperkalemia, Chronic Kidney Disease, hyperkalemia, ambulatory CKD, CKD, chronic kidney disease, ECG