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

NCT ID: NCT07210021

Last Updated: 2025-10-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-10-14
• Study Completion Date: 2025-11-28

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.

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 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

Conditions

Hyperkalemia; Chronic Kidney Disease (Stage 3-4)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

AK+ Guard™ ECG Application

Intervention Type: 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).

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.

AK+ Guard™ ECG Application

Intervention Type: 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).

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).

Intervention Type: DEVICE

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

• 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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AccurKardia, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Jersey Kidney Care - Hypertension & Nephrology Associates

Eatontown, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Moin Hussaini

Role: CONTACT

mhussaini@accurkardia.com

718-708-3522

Facility Contacts

Danit Silberman

Role: primary

danitsilb@gmail.comEatontown

732-460-1200

Other Identifiers

AKG CKD 002A, AKG CKD 002B

Identifier Type: -

Identifier Source: org_study_id