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Pilot Study of AK+ Guard™ for Hyperkalemia in Chronic Kidney Disease

This observational pilot study is testing a new software called AK+ Guard™. This software uses artificial intelligence to analyze your heart's electrical activity (ECG) to detect high potassium levels (hyperkalemia) in people with chronic kidney disease (CKD). The study aims to see how well AK+ Guard™ can identify moderate to severe hyperkalemia (serum potassium ≥ 6.5 mmol/L) and how easy it is for people to use daily. You might be able to join if you are 22 or older, have CKD stages III-IV, and have had high potassium or are on certain medications. The study is currently recruiting 50 participants.

Study design
This is an observational pilot study with 50 planned participants. It is evaluating the diagnostic accuracy and usability of the AK+ Guard™ ECG Application.
What's involved
You would have an outpatient serum potassium laboratory test at the start. If in the remote monitoring arm, you would complete daily ECGs for up to 4 weeks and a usability survey at the end.
Compensation
Not stated in the trial record.
Follow-up
Participants in the remote monitoring arm are followed for daily compliance up to 4 weeks (Day 28).

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NCT07210021

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

Recruiting
Not specifiedAges 22+Observational
AccurKardia, Inc.
~50 participants
Updated 2025-10-16 on ClinicalTrials.gov
What's tested:AK+ Guard™ ECG Application

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/L
Measured over Baseline (Day 0)
+3 more outcomes measured

Conditions

Hyperkalemia
Chronic Kidney Disease (Stage 3-4)

Explore related trials

Chronic Kidney DiseaseHyperkalemia

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Moin Hussaini
[email protected]
718-708-3522
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Completion of Arm 2A visit
Owns an iPhone compatible with the study application

Exclusion

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

What this trial measures

  • Arm 2A: Sensitivity and specificity of AK+ Guard™ for detecting serum potassium greater than or equal to 6.5 mmol/LBaseline (Day 0)

    Defined as serum K+ ≥ 6.5 mmol/L

  • 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) scoreStudy 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)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.