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

Last updated: October 14, 2025
Sponsor: AccurKardia, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

AK+ Guard™ ECG Application

Clinical Study ID

NCT07210021
AKG CKD 002A, AKG CKD 002B
  • Ages > 22
  • All Genders

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: AK+ Guard™ ECG Application
Phase:
Study Start date:
October 14, 2025
Estimated Completion Date:
November 28, 2025

Study Description

The AK+ Guard™ application is an investigational Software as a Medical Device (SaMD) developed by AccurKardia, Inc. (New York, USA). It is designed to aid in the diagnosis of moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L) in adults using artificial intelligence analysis of Lead I electrocardiogram (ECG) data. The software is intended as a clinical decision support tool for adults at risk of hyperkalemia, including but not limited to those with end-stage renal disease (ESRD), chronic kidney disease (CKD) on renin-angiotensin-aldosterone system inhibitors, heart failure, adrenal disorders, and patients taking aldosterone synthase inhibitors. The AK+ Guard™ application analyzes only Lead I ECG signals, which may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch).

This pilot study is designed to generate preliminary real-world evidence on both the diagnostic performance of the application and its usability in daily life. The study includes two arms:

Arm 2A - Outpatient Diagnostic Accuracy:

  • Estimate sensitivity, specificity, PPV, and NPV of AK+ Guard™ in ambulatory CKD stages III-IV

  • Evaluate interoperability across selected Lead I ECG capture devices (Apple Watch, HeartBeam, and 12 lead reference)

  • Characterize system reliability metrics (upload success, algorithm runtime) in the outpatient setting

Arm 2B - Remote Patient Monitoring

  • Quantify participant compliance, data completeness, and attrition during four week remote monitoring

  • Evaluate user experience using System Usability Scale (SUS) score, Net Promoter Score (NPS), and semi structured feedback

  • Capture technical performance metrics in a real world, unsupervised context

Connect with a study center

  • Central Jersey Kidney Care - Hypertension & Nephrology Associates

    Eatontown 5097482, New Jersey 5101760 07724
    United States

    Active - Recruiting

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