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

NCT07210021 | Recruiting

• 1 other identifier: AKG CKD 002A, AKG CKD 002B
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Hyperkalemia; Chronic Kidney Disease (Stage 3-4)

Keywords

hyperkalemia; ambulatory CKD; CKD; chronic kidney disease; ECG

Outcome Measures

Primary Outcomes (4)

• 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

  Baseline (Day 0)

• Arm 2B: (a) Daily compliance rate (proportion of completed ECGs out of scheduled ECGs)

  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.

  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.

  Study completion at Week 4 (Day 28)

Secondary Outcomes (9)

• Arm 2A: Positive Predictive Value (PPV)

  Baseline (Day 0)

• Arm 2A: Negative Predictive Value (NPV)

  Baseline (Day 0)

• Arm 2A: Device specific concordance

  Baseline (Day 0)

• Arm 2A: Algorithm runtime

  Baseline (Day 0)

• Arm 2A: Upload success rate

  Baseline (Day 0)

Other Outcomes (5)

• Arm 2A (Exploratory): Sensitivity (stratified)

  Baseline (Day 0)

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

  Baseline (Day 0)

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

  Baseline (Day 0)

Study Arms (2)

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).

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.

Device: AK+ Guard™ ECG Application

Interventions

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).

Arm 2A - Outpatient Diagnostic Accuracy; Arm 2B - Remote Patient Monitoring

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• AccurKardia, Inc.: lead

Study Sites (1)

Central Jersey Kidney Care - Hypertension & Nephrology Associates

Eatontown, New Jersey, 07724, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

For this study, no biospecimens are being collected by the investigators. Rather, the study is collecting ECGs at the time of routine clinical blood draws for serum potassium labs. The study is only retaining the laboratory result for serum potassium. The laboratory is obtaining the serum.

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Moin Hussaini

CONTACT

718-708-3522; mhussaini@accurkardia.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 7, 2025
• Study Start: October 14, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 28, 2025
• Last Updated: October 16, 2025

Record last verified: 2025-10

Locations

US (1)