An observational study in Hyperkalemia and Chronic Kidney Disease (Stage 3-4), sponsored by AccurKardia, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by AccurKardia, Inc. · Observational
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:
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 hyperkalemia (serum potassium ≥ 6.5 mmol/L) in adults using artificial intelligence analysis of Lead I electrocardiogram (ECG) data. The software is intended as a clinical decision support tool for adults at risk of hyperkalemia, including but not limited to those with end-stage renal disease (ESRD), chronic kidney disease (CKD) on renin-angiotensin-aldosterone system inhibitors, heart failure, adrenal disorders, and patients taking aldosterone synthase inhibitors. The AK+ Guard™ application analyzes only Lead I ECG signals, which may be obtained from standard 12-lead ECGs, clinical-grade ECG devices with Lead I capability, or consumer wearable devices (e.g., Apple Watch).
This pilot study is designed to generate preliminary real-world evidence on both the diagnostic performance of the application and its usability in daily life. The study includes two arms:
Arm 2A - Outpatient Diagnostic Accuracy:
Arm 2B - Remote Patient Monitoring
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's planned enrollment of 50 is below the median of 459 across 30 observational studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →AccurKardia, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
(Arm 2A - Outpatient Diagnostic Accuracy)
(Arm 2B - Remote Patient Monitoring)
Exclusion Criteria (Both arms):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with chronic kidney disease (CKD) stages III-IV who are scheduled for a routine outpatient potassium blood test. At the same clinic visit, participants will have ECGs recorded using three devices (12-lead ECG, Apple Watch, and HeartBeam) for analysis by the AK+ Guard™ software. Researchers will compare the software's results with the laboratory potassium values to estimate sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV).
Device: AK+ Guard™ ECG Application
A subset of participants from Arm 2A (Outpatient Diagnostic Accuracy) who agree to continue with at-home monitoring for up to four weeks. These participants will use an Apple Watch and study application to record daily ECGs. They will complete short weekly surveys about ease of use, anxiety, and safety perceptions, and return for a confirmatory laboratory test if the AK+ Guard™ software signals possible high potassium. Researchers will assess daily compliance, usability, and overall system reliability in a real-world setting.
Device: AK+ Guard™ ECG Application
An 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).
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)
Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs)
Time frame: Daily monitoring up to 4 weeks (Day 28)
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)
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)
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)
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)
Arm 2A: Device specific concordance
Percentage (%) of device-detected results that agree with outpatient laboratory results.
Time frame: Baseline (Day 0)
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)
Arm 2A: Upload success rate
Percentage (%) of attempted ECG uploads that successfully complete without failure.
Time frame: Baseline (Day 0)
Arm 2B: Data completeness
Percentage (%) of scheduled ECGs that are successfully completed.
Time frame: Daily monitoring up to 4 weeks (Day 28)
Arm 2B: System reliability (application ("app") crash rate, upload failure less than 2 percent (%))
Time frame: Daily monitoring up to 4 weeks (Day 28)
Arm 2B: Number of service calls per participant
Time frame: Daily monitoring up to 4 weeks (Day 28)
Arm 2B: False positive alarm rate (less than 20%)
Percentage (%) of alarms generated by AK+ Guard™ that are not confirmed as true clinical events by outpatient laboratory results.
Time frame: Daily monitoring up to 4 weeks (Day 28)
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)
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)
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)
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)
Arm 2B (Exploratory): Participant anxiety and comfort
Change from baseline in survey responses on reassurance and anxiety, and comfort with using AK+ Guard™. 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)
Plan to share: Undecided
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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AccurKardia, Inc.