Recruiting

AK+ Guard™

Sponsor:

AccurKardia, Inc.

Code:

NCT07210021

Conditions

Hyperkalemia

Chronic Kidney Disease (Stage 3-4)

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

AK+ Guard™ ECG Application

Study Details

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+) ≥ 6.5 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.

Conditions

Hyperkalemia

Chronic Kidney Disease (Stage 3-4)

Study ID

NCT07210021

Start date

Oct 14, 2025

Status verified date

Oct, 2025

Completion date

Nov 28, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

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 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.

Interventions

AK+ 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).

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) ]
  • Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs) [ Time Frame: Daily monitoring up to 4 weeks (Day 28) ]
  • Arm 2B: (b) Mean System Usability Scale (SUS) score [ Time Frame: Study completion at Week 4 (Day 28) ]
  • Arm 2B: (c) Net Promoter Score (NPS) [ Time Frame: Study completion at Week 4 (Day 28) ]

Central Contacts and Locations

Central contacts

Moin Hussaini

718-708-3522mhussaini@accurkardia.com

Locations

Central Jersey Kidney Care - Hypertension & Nephrology Associates

Recruiting

Eatontown, New Jersey, United States, 07724

Contacts

Danit Silberman

732-460-1200danitsilb@gmail.comEatontown

More Information

Sponsor

AccurKardia, Inc.

Last update posted

Oct 16, 2025

Last verified

Oct, 2025

Keywords

  • hyperkalemia
  • ambulatory CKD
  • CKD
  • chronic kidney disease
  • ECG

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by AccurKardia, Inc. on 2025-10-16.