Status:
RECRUITING
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Lead Sponsor:
AccurKardia, Inc.
Conditions:
Hyperkalemia
Chronic Kidney Disease (Stage 3-4)
Eligibility:
All Genders
22+ years
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....
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 hyperk...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 28 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07210021
Start Date
October 14 2025
End Date
November 28 2025
Last Update
October 16 2025
Active Locations (1)
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1
Central Jersey Kidney Care - Hypertension & Nephrology Associates
Eatontown, New Jersey, United States, 07724