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
This trial does not accept healthy volunteersQualifiers
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 population
Participants will be adults aged 22 years or older with chronic kidney disease (CKD) stages III-IV who receive care at Central Jersey Kidney Care, an outpatient nephrology clinic. Eligible participants for Arm 2A will be identified at the time of a routine outpatient potassium blood draw. A subset of participants who complete Arm 2A will be invited to enroll in Arm 2B, which involves daily remote monitoring at home for up to four weeks. Participants must have an iPhone compatible with the study application to join Arm 2B.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
AK+ Guard™ ECG Application
DeviceAn investigational Software as a Medical Device (SaMD) that analyzes Lead I electrocardiogram (ECG) data using artificial intelligence to detect moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L). ECG inputs may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch, HeartBeam).
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Arm 2A - Outpatient Diagnostic Accuracy1 intervention
Group B: Arm 2B - Remote Patient Monitoring1 intervention
Trial outcomes
Primary outcomes
1
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L
Defined as serum K+ ≥ 6.5 mmol/L
Time frame
Baseline (Day 0)2
Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs)
Time frame
Daily monitoring up to 4 weeks (Day 28)3
Arm 2B: (b) Mean System Usability Scale (SUS) score
10-item scale with final score between 0 and 100. The SUS score is an index of perceived usability (not a percentage), with higher scores indicating better usability. A score above 68 is generally considered above average usability, while lower scores suggest more usability concerns. The reported outcome will be the mean SUS score across participants.
Time frame
Study completion at Week 4 (Day 28)4
Arm 2B: (c) Net Promoter Score (NPS)
Participant-reported likelihood of recommending the system to others, measured on a 0-10 scale, with higher scores indicating greater likelihood to recommend. Individual responses are converted into a Net Promoter Score (NPS), which ranges from -100 to +100. Positive values (\>0) indicate overall customer loyalty and advocacy.
Time frame
Study completion at Week 4 (Day 28)Secondary outcomes
1
Arm 2A: Positive Predictive Value (PPV)
Percentage (%) of positive hyperkalemia alerts generated by AK+ Guard™ that are confirmed as true positives by outpatient laboratory results.
Time frame
Baseline (Day 0)2
Arm 2A: Negative Predictive Value (NPV)
Percentage (%) of negative results generated by AK+ Guard™ that are confirmed as true negatives by outpatient laboratory results.
Time frame
Baseline (Day 0)3
Arm 2A: Device specific concordance
Percentage (%) of device-detected results that agree with outpatient laboratory results.
Time frame
Baseline (Day 0)4
Arm 2A: Algorithm runtime
Time in seconds (s) required for the AK+ Guard™ algorithm to complete analysis, defined as the total of transmission time, processing time, and time to return results.
Time frame
Baseline (Day 0)Other outcomes
1
Arm 2A (Exploratory): Sensitivity (stratified)
Sensitivity of AK+ Guard™ for detecting serum K+ ≥ 6.5 mmol/L, stratified by CKD stage, renin-angiotensin-aldosterone system inhibitor (RAASi) use, and comorbidity profile. Reported as point estimate (%) with confidence interval.
Time frame
Baseline (Day 0)2
Arm 2A (Exploratory): Positive Predictive Value (PPV, stratified)
PPV of AK+ Guard™ for detecting serum K+ ≥ 6.5 mmol/L, stratified by CKD stage, renin-angiotensin-aldosterone system inhibitor (RAASi) use, and comorbidity profile. Reported as point estimate (%) with confidence interval.
Time frame
Baseline (Day 0)3
Arm 2A (Exploratory): Negative Predictive Value (NPV, stratified)
NPV of AK+ Guard™ for detecting serum K+ ≥ 6.5 mmol/L, stratified by CKD stage, renin-angiotensin-aldosterone system inhibitor (RAASi) use, and comorbidity profile. Reported as point estimate (%) with confidence interval.
Time frame
Baseline (Day 0)4
Arm 2B (Exploratory): Participant perception of medication safety
Change from baseline in survey responses on perceived benefit of AK+ Guard™ for monitoring potassium and identifying dangerous levels earlier. Each item is rated on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree).
Time frame
Baseline (Day 0) and at study completion (Day 28)Sponsors and contacts
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Source ClinicalTrials.gov