Actively Recruiting
Diagnostic Accuracy and Usability of the AK+ Guard 21 ECG Application for Hyperkalemia Detection in Adults with Chronic Kidney Disease (Outpatient and Remote Monitoring)
Led by AccurKardia, Inc. · Updated on 2025-10-16
50
Participants Needed
1
Research Sites
3 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the AK+ Guard 21 software, an investigational medical device designed to detect moderate to severe hyperkalemia (high potassium levels) in adults with chronic kidney disease (CKD) stages III-IV. This observational pilot study aims to assess the diagnostic accuracy of the software in an outpatient setting and its usability and reliability during daily remote monitoring. The study focuses on adults at risk of hyperkalemia, including those on specific kidney-related therapies, by analyzing Lead I ECG data from standard or wearable devices. The study includes two arms: Arm 2A involves participants scheduled for routine outpatient potassium blood tests who will have ECGs recorded using three devices (12-lead ECG, Apple Watch, HeartBeam). The software's diagnostic performance for detecting high potassium is compared to lab results. Arm 2B includes a subset of these participants who agree to use the Apple Watch and study app for daily ECG recordings at home for up to four weeks. Participants also complete weekly surveys and may return for confirmatory lab tests if high potassium is indicated. Participants will have ECGs collected and compared to blood potassium levels to evaluate sensitivity, specificity, and other diagnostic measures. During the remote monitoring phase, researchers will track daily compliance, data completeness, and system reliability, including app performance and user experience through surveys. The study measures include diagnostic accuracy at baseline and usability scores after four weeks. The total participation duration varies with the arm, including up to four weeks of remote monitoring.
CONDITIONS
Brief Title
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 22 years or older
- Chronic kidney disease stages III-IV managed at the outpatient clinic
- Scheduled outpatient serum potassium laboratory test
- On renin-angiotensin-aldosterone system inhibitor therapy or documented high potassium (K+ 65 5.5 mmol/L) within the past 12 months
- Able to provide written informed consent
- Completion of Arm 2A visit for remote monitoring
- Owns an iPhone compatible with the study app
You will not qualify if you...
- Age 21 years or younger
- Presence of pacemaker or implantable cardioverter defibrillator
- Pre-existing left or right bundle branch block, intraventricular conduction delay, or significant hypocalcemia
- Potassium lowering treatment before Lead I ECG acquisition
- Trauma, acute events, or active interventions affecting potassium balance
- Physical limitations preventing ECG recording
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants with chronic kidney disease stages III-IV attend a routine outpatient visit for serum potassium blood testing and have ECGs recorded using three devices (12-lead ECG, Apple Watch, and HeartBeam) to evaluate the AK+ Guard™ software's diagnostic accuracy.
1 visit (in-person)
Duration - Up to 4 weeks
A subset of participants use an Apple Watch and study app to record daily ECGs at home for up to 4 weeks. They complete weekly surveys on usability and safety, and may return for confirmatory lab testing if needed.
Daily ECG recordings and weekly surveys; occasional visits if high potassium is indicated
Trial Site Locations
Total: 1 location
1
Central Jersey Kidney Care - Hypertension & Nephrology Associates
Eatontown, New Jersey, United States, 07724
Actively Recruiting
Research Team
M
Moin Hussaini
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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