NCT06901960 Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5
| NCT ID | NCT06901960 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Chronic Kidney Disease (Stages 3b-5) |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,066 participants |
| Start Date | 2025-04-02 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,066 participants in total. It began in 2025-04-02 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.0 mmol/L during 6 months of follow-up). It will also learn about the adherence of using a mobile monitoring device. Participants will: * Measure their serum potassium using an AI-enhanced point-of-care ECG device at least twice per week * Receive health education prompts to reduce intake of potassium rich foods if their electrocardiogram device measured serum potassium is abnormal * Receive alerts to visit nephrology clinic if their electrocardiogram device measured serum potassium is continuously abnormal
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06901960 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Kidney Disease (Stages 3b-5). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06901960 currently recruiting?
Yes, NCT06901960 is actively recruiting participants. Contact the research team at wangjinwei@bjmu.edu.cn for enrollment information.
Where is the NCT06901960 trial being conducted?
This trial is being conducted at Beijing, China, Nanning, China, Wuhan, China.
Who is sponsoring the NCT06901960 clinical trial?
NCT06901960 is sponsored by Peking University First Hospital. The trial plans to enroll 1,066 participants.
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