RecruitingNCT07210021

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)

Sponsor

AccurKardia, Inc.

Enrollment

50 participants

Start Date

Oct 14, 2025

Study Type

OBSERVATIONAL

Conditions

Hyperkalemia Chronic Kidney Disease (Stage 3-4)

Summary

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.

Eligibility

Min Age: 22 Years

Plain Language Summary

Simplified for easier understanding

This study tests a wearable device called AK+ Guard™ that monitors potassium levels through the skin using ECG-like technology. It aims to see how accurately it can detect high potassium — a dangerous condition for people with chronic kidney disease (CKD) — compared to standard blood tests. **You may be eligible if...** - You are 22 or older with CKD stages 3 or 4 - You are seen at Central Jersey Kidney Care outpatient clinic - You are on a medication that affects the kidney-hormone system (RAASi), or you have had high potassium in the past 12 months - For remote monitoring arm: you own a compatible iPhone **You may NOT be eligible if...** - You have a pacemaker or implanted heart device - You have certain pre-existing heart conduction problems or severe low calcium - You have received potassium-lowering treatment before the scheduled blood test - You are under 22 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAK+ Guard™ ECG Application

An investigational Software as a Medical Device (SaMD) that analyzes Lead I electrocardiogram (ECG) data using artificial intelligence to detect moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L). ECG inputs may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch, HeartBeam).

Locations(1)

Central Jersey Kidney Care - Hypertension & Nephrology Associates

Eatontown, New Jersey, United States

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NCT07210021

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