AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorAccurKardia, Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- AK+ Guard™ ECG Application
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov