HyperkalemiaNCT07210021
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
An observational study of Hyperkalemia and Chronic Kidney Disease (Stage 3-4), run by AccurKardia, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
- What is being tested?
- AK+ Guard™ ECG Application
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2025to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- (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
Show all 9Show fewer
- (Arm 2B - Remote Patient Monitoring)
- Completion of Arm 2A visit
- Owns an iPhone compatible with the study application
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Central Jersey Kidney Care - Hypertension & Nephrology Associates
Eatontown, New Jersey, 07724
About this study
Official title: 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)
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.
Read the detailed description
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:
- Estimate sensitivity, specificity, PPV, and NPV of AK+ Guard™ in ambulatory CKD stages III-IV
- Evaluate interoperability across selected Lead I ECG capture devices (Apple Watch, HeartBeam, and 12 lead reference)
- Characterize system reliability metrics (upload success, algorithm runtime) in the outpatient setting
Arm 2B - Remote Patient Monitoring
- Quantify participant compliance, data completeness, and attrition during four week remote monitoring
- Evaluate user experience using System Usability Scale (SUS) score, Net Promoter Score (NPS), and semi structured feedback
- Capture technical performance metrics in a real world, unsupervised context
- Conditions
- Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
- Being tested
- AK+ Guard™ ECG Application
- Keywords
- hyperkalemia, ambulatory CKD, CKD, chronic kidney disease, ECG
- Medical subject headings
- Hyperkalemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK+ Guard™ ECG ApplicationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Arm 2A - Outpatient Diagnostic Accuracy | 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). Receives: Device: AK+ Guard™ ECG Application | |
| Arm 2B - Remote Patient Monitoring | 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. Receives: Device: AK+ Guard™ ECG Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 0)
Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs)
Measured: 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.
Measured: 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.
Measured: Study completion at Week 4 (Day 28)
Secondary outcomes (9)
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.
Measured: 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.
Measured: Baseline (Day 0)
Arm 2A: Device specific concordance
Percentage (%) of device-detected results that agree with outpatient laboratory results.
Measured: 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.
Measured: Baseline (Day 0)
Arm 2A: Upload success rate
Percentage (%) of attempted ECG uploads that successfully complete without failure.
Measured: Baseline (Day 0)
Arm 2B: Data completeness
Percentage (%) of scheduled ECGs that are successfully completed.
Measured: Daily monitoring up to 4 weeks (Day 28)
Arm 2B: System reliability (application ("app") crash rate, upload failure less than 2 percent (%))
Measured: Daily monitoring up to 4 weeks (Day 28)
Arm 2B: Number of service calls per participant
Measured: 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.
Measured: Daily monitoring up to 4 weeks (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start14 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AccurKardia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07210021
- Sponsor's protocol ID
- AKG CKD 002A, AKG CKD 002B
- Status last verified
- Oct 2025
- First submitted
- 15 Sep 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07210021
- Acronym / sponsor ID
- AKG CKD 002A, AKG CKD 002B
- Conditions
- Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
- Keywords
- hyperkalemia, ambulatory CKD, CKD, chronic kidney disease, ECG
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- AccurKardia, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 7 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Estimate sensitivity, specificity, PPV, and NPV of AK+ Guard™ in ambulatory CKD stages III-IV
- Evaluate interoperability across selected Lead I ECG capture devices (Apple Watch, HeartBeam, and 12 lead reference)
- Characterize system reliability metrics (upload success, algorithm runtime) in the outpatient setting
Arm 2B - Remote Patient Monitoring
- Quantify participant compliance, data completeness, and attrition during four week remote monitoring
- Evaluate user experience using System Usability Scale (SUS) score, Net Promoter Score (NPS), and semi structured feedback
- Capture technical performance metrics in a real world, unsupervised context
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 2A - Outpatient Diagnostic Accuracy | – | Device: AK+ Guard™ ECG ApplicationParticipants 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). |
| Arm 2B - Remote Patient Monitoring | – | Device: AK+ Guard™ ECG ApplicationA 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (9 listed)
- (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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK+ Guard™ ECG ApplicationAn 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). | Device | Arm 2A - Outpatient Diagnostic Accuracy, Arm 2B - Remote Patient Monitoring |
Primary outcome
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L
Time frame: Baseline (Day 0)
Defined as serum K+ ≥ 6.5 mmol/L
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
Time frame: Study completion at Week 4 (Day 28)
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.
Arm 2B: (c) Net Promoter Score (NPS)
Time frame: Study completion at Week 4 (Day 28)
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.
9 secondary outcomes
Arm 2A: Positive Predictive Value (PPV)
Time frame: Baseline (Day 0)
Arm 2A: Negative Predictive Value (NPV)
Time frame: Baseline (Day 0)
Arm 2A: Device specific concordance
Time frame: Baseline (Day 0)
Arm 2A: Algorithm runtime
Time frame: Baseline (Day 0)
Arm 2A: Upload success rate
Time frame: Baseline (Day 0)
Arm 2B: Data completeness
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%)
Time frame: Daily monitoring up to 4 weeks (Day 28)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hyperkalemia
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
RecruitingPhase 2
Effect of Patiromer in Children Under 12 Years of Age With High Blood Potassium Levels
Hyperkalemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia and Chronic Kidney Disease (Stage 3-4), run by AccurKardia, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L (time frame: Baseline (Day 0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.