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NCT Number: NCT07210021

AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring

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.

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Key information

Conditions

Hyperkalemia Chronic Disease Chronic Kidney Disease (Stage 3-4) Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Central Jersey Kidney Care - Hypertension & Nephrology Associates

Eatontown, New Jersey, 07724, United States

Location status: Recruiting

Location contact

Danit Silberman

CONTACT

[email protected]

732-460-1200

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AK+ Guard™ ECG Application

Device

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).

Primary outcomes

  1. 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

  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

    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.

  4. 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.

Secondary outcomes

  1. Arm 2A: Positive Predictive Value (PPV)

    Time frame: Baseline (Day 0)

    Percentage (%) of positive hyperkalemia alerts generated by AK+ Guard™ that are confirmed as true positives by outpatient laboratory results.

  2. Arm 2A: Negative Predictive Value (NPV)

    Time frame: Baseline (Day 0)

    Percentage (%) of negative results generated by AK+ Guard™ that are confirmed as true negatives by outpatient laboratory results.

  3. Arm 2A: Device specific concordance

    Time frame: Baseline (Day 0)

    Percentage (%) of device-detected results that agree with outpatient laboratory results.

  4. Arm 2A: Algorithm runtime

    Time frame: Baseline (Day 0)

    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.

  5. Arm 2A: Upload success rate

    Time frame: Baseline (Day 0)

    Percentage (%) of attempted ECG uploads that successfully complete without failure.

  6. Arm 2B: Data completeness

    Time frame: Daily monitoring up to 4 weeks (Day 28)

    Percentage (%) of scheduled ECGs that are successfully completed.

  7. Arm 2B: System reliability (application ("app") crash rate, upload failure less than 2 percent (%))

    Time frame: Daily monitoring up to 4 weeks (Day 28)

  8. Arm 2B: Number of service calls per participant

    Time frame: Daily monitoring up to 4 weeks (Day 28)

  9. Arm 2B: False positive alarm rate (less than 20%)

    Time frame: Daily monitoring up to 4 weeks (Day 28)

    Percentage (%) of alarms generated by AK+ Guard™ that are not confirmed as true clinical events by outpatient laboratory results.

Other outcomes

  1. Arm 2A (Exploratory): Sensitivity (stratified)

    Time frame: Baseline (Day 0)

    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.

  2. Arm 2A (Exploratory): Positive Predictive Value (PPV, stratified)

    Time frame: Baseline (Day 0)

    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.

  3. Arm 2A (Exploratory): Negative Predictive Value (NPV, stratified)

    Time frame: Baseline (Day 0)

    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.

  4. Arm 2B (Exploratory): Participant perception of medication safety

    Time frame: Baseline (Day 0) and at study completion (Day 28)

    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).

  5. Arm 2B (Exploratory): Participant anxiety and comfort

    Time frame: Baseline (Day 0) and at study completion (Day 28)

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Moin Hussaini

CONTACT

[email protected]

718-708-3522

Sponsors and collaborators

Lead sponsor

AccurKardia, Inc.

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 7, 2025
Registry last updated
Oct 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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