Status:

RECRUITING

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

Lead Sponsor:

AccurKardia, Inc.

Conditions:

Hyperkalemia

Chronic Kidney Disease (Stage 3-4)

Eligibility:

All Genders

22+ years

Brief 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....

Detailed 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 hyperk...

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

Key Trial Info

Start Date :

October 14 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 28 2025

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT07210021

Start Date

October 14 2025

End Date

November 28 2025

Last Update

October 16 2025

Active Locations (1)

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Central Jersey Kidney Care - Hypertension & Nephrology Associates

Eatontown, New Jersey, United States, 07724

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