NCT07210021 AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
| NCT ID | NCT07210021 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AccurKardia, Inc. |
| Condition | Hyperkalemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-10-14 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-10-14 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 (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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07210021 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Hyperkalemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07210021 currently recruiting?
Yes, NCT07210021 is actively recruiting participants. Contact the research team at mhussaini@accurkardia.com for enrollment information.
Where is the NCT07210021 trial being conducted?
This trial is being conducted at Eatontown, United States.
Who is sponsoring the NCT07210021 clinical trial?
NCT07210021 is sponsored by AccurKardia, Inc.. The trial plans to enroll 50 participants.