An observational study in Hyperkalemia and Chronic Kidney Disease, sponsored by Kyungho Park. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-03-20.
Sponsored by Kyungho Park · Observational
This study aims to evaluate whether hyperkalemia, a potentially life-threatening condition in dialysis patients, can be detected early using a wearable single-lead ECG device. Patients with chronic kidney disease undergoing hemodialysis will wear a chest-attached ECG sensor (HiCardi) during dialysis sessions. ECG data will be collected four times over six weeks, in coordination with routine blood tests measuring serum potassium levels. The goal is to analyze changes in ECG waveforms, such as T waves, and determine if these correlate with elevated potassium levels. The study is non-interventional and observational, focusing on real-time, non-invasive monitoring. It is expected to improve clinical decision-making by enabling early detection of hyperkalemia without additional blood tests.
133 studies on the registry are indexed under Hyperkalemia; 25 are open to participants now.
This study's enrollment of 32 is below the median of 459 across 30 observational studies indexed under Hyperkalemia.
Browse Hyperkalemia studies →This is the only study on the registry with Kyungho Park as lead sponsor.
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Patients with chronic kidney disease undergoing regular hemodialysis at Chungnam National University Hospital. Participants are selected based on clinical stability and willingness to provide informed consent. The population includes both male and female adults without age restriction.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with chronic kidney disease receiving maintenance hemodialysis three times per week. Participants will wear a HiCardi single-lead wearable ECG device during dialysis sessions for 8 weeks. ECG data will be collected four times in coordination with routine blood potassium tests to evaluate the correlation between ECG waveform changes and hyperkalemia.
Device: HiCardi wearable ECG
A chest-attached, single-lead wearable ECG device used to collect real-time ECG data from hemodialysis patients. The device records ECG waveforms during dialysis sessions and transmits the data to a secure cloud platform. This non-invasive tool is used to analyze T-wave morphology for early detection of hyperkalemia in patients with chronic kidney disease.
Correlation between EKG characteristics and serum potassium level
The primary outcome is the correlation between EKG characteristics (e.g., T wave amplitude, QRS duration, P wave morphology) measured using a wearable single-lead ECG device and serum potassium levels obtained from blood tests. Data will be collected at four time points over 8 weeks.
Time frame: Week 0, Week 2, Week 4, Week 6
Plan to share: No — Individual participant data (IPD) will not be shared because the data include sensitive clinical and biometric information that may risk participant privacy. In addition, there is no current plan or infrastructure in place to support external data requests.
No publications or documents are linked to this record.
Ran from Jun 2025 to primary completion in Aug 2025, 2 months.
Of 20 observational studies under Hyperkalemia, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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