NCT07210021Enrolling by invitation
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Diagnostic Accuracy, Usability, Patient Compliance, and System Reliability of the AK+ Guard™ ECG Application for Hyperkalemia Prediction in Ambulatory Chronic Kidney Disease Patients (Outpatient and Remote Monitoring Arms)
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 14 Oct 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- AccurKardia, Inc.
- Diseases
- Chronic kidney disease
- NCT number
- NCT07210021
What you commit to
- Study type: Observational
- Planned participants: 50
- From 14 Oct 2025 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Potassium lowering treatment administered before Lead I ECG acquisition
- Trauma, acute events, or active interventions altering potassium homeostasis
Age
- Age 21 years or younger
Other
- 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
- Physical limitation precluding ECG acquisition
Who the study is looking for
- (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
Age in the registry: 22 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Central Jersey Kidney Care - Hypertension & Nephrology Associates Coordinator of this site? Confirm its status | Eatontown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.