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

Part of paid clinical trials in Eatontown, New Jersey.

Sponsor
AccurKardia, Inc.
Study ID
NCT07210021
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AK+ Guard™ ECG Application — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Oct 14, 2025
Status verified
Oct 2025
Primary completion
Nov 30, 2025
Completion
Nov 28, 2025

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Arm 2A - Outpatient Diagnostic Accuracy
    Participants with chronic kidney disease (CKD) stages III-IV who are scheduled for a routine outpatient potassium blood test. At the same clinic visit, participants will have ECGs recorded using three devices (12-lead ECG, Apple Watch, and HeartBeam) for analysis by the AK+ Guard™ software. Researchers will compare the software's results with the laboratory potassium values to estimate sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
  • Arm: Arm 2B - Remote Patient Monitoring
    A subset of participants from Arm 2A (Outpatient Diagnostic Accuracy) who agree to continue with at-home monitoring for up to four weeks. These participants will use an Apple Watch and study application to record daily ECGs. They will complete short weekly surveys about ease of use, anxiety, and safety perceptions, and return for a confirmatory laboratory test if the AK+ Guard™ software signals possible high potassium. Researchers will assess daily compliance, usability, and overall system reliability in a real-world setting.

Primary Outcome Measure

Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L [ Time Frame: Baseline (Day 0) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Central Jersey Kidney Care - Hypertension & Nephrology AssociatesEatontownNew Jersey07724
Danit Silberman
[email protected]
732-460-1200

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Central Jersey Kidney Care - Hypertension & Nephrology Associates· Eatontown, NJ

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