Actively Recruiting
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Led by AccurKardia, Inc. · Updated on 2025-10-16
50
Participants Needed
1
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Diagnosed with chronic kidney disease stages III-IV managed at Central Jersey Kidney Care outpatient clinic
- Scheduled for outpatient serum potassium laboratory testing
- Currently on renin-angiotensin-aldosterone system inhibitor therapy or have documented hyperkalemia (K+ 2 5.5 mmol/L) within the past 12 months
- Able to provide written informed consent
- Completed Arm 2A visit (for Arm 2B participants)
- Owns an iPhone compatible with the study application (for Arm 2B participants)
You will not qualify if you...
- Age 21 years or younger
- Presence of 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
- Receiving potassium lowering treatment before Lead I ECG acquisition
- Recent trauma, acute events, or active interventions affecting potassium balance
- Physical limitations preventing ECG acquisition
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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