AI-enabled ECG potassium monitoring for people with stage 3b–5 chronic kidney disease
Official title: Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5 to Reduce Rate of Hyperkalemia - a Practical Randomized Clinical Trial
Run by Peking University First Hospital · NCT06901960 · Data updated 2026-11-12
This project will test whether using a handheld AI ECG device to check potassium twice weekly helps adults with CKD stages 3b–5 avoid high potassium levels.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 1066 (estimated) |
| Sponsor | Peking University First Hospital Academic / other |
| Locations | 3 sites (Beijing, Beijing Municipality and 2 other locations) |
| Status | Recruiting |
| Started | April 2, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT06901960 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with CKD stages 3b–5 (eGFR 10–<45 mL/min/1.73 m2) who have regular visits at the participating sites and are willing and able to use a mobile ECG device, and who are not on kidney replacement therapy.
✕Probably not a fit
Patients already on dialysis or expected to start kidney replacement within six months, those with implanted pacemakers, or those unable or unwilling to use the device are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In an outpatient setting, participants with moderate-to-advanced chronic kidney disease will use a point-of-care AI-enhanced ECG device at least twice weekly to estimate their serum potassium category over six months. The device classifies potassium into four bands (<5.0, 5.0–<5.5, 5.5–<6.0, and ≥6.0 mmol/L) and delivers health-education prompts when readings are abnormal. Persistent abnormal readings trigger alerts advising participants to visit their nephrology clinic. The study will measure whether this frequent, patient-led monitoring reduces the occurrence of serum potassium ≥5.0 mmol/L and will track participant adherence to the monitoring regimen.
Why it matters
Potential benefit: If successful, this approach could reduce episodes of high potassium and prompt earlier clinic care to prevent complications from hyperkalemia.
How similar studies have gone: Prior studies have demonstrated that AI applied to ECGs can estimate serum potassium with reasonable accuracy, but deploying a patient-facing home AI-ECG program to reduce hyperkalemia events remains largely untested in routine clinical practice.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with chronic kidney disease stages 3b-5 (eGFR: 10 - \<45 ml/min/1.73m²) * Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment) * Willingness to participate in the study with signed informed consent Exclusion Criteria: * Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months * Unwillingness or without the ability to monitor hyperkalemia using the study device * Patients with heart pacemaker implanted
Where it's running
-
Peking University First Hospital
Beijing, Beijing Municipality, China Recruiting -
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China Not yet recruiting -
Hubei Provincial Hospital of TCM
Wuhan, Hubei, China Not yet recruiting
Study contacts
- Study coordinator: Jinwei Wang, Ph.D.
- Email: wangjinwei@bjmu.edu.cn
- Phone: +86-010-83572388
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.