HyperkalemiaNCT07054905
Prediction of Hyperkalemia in Dialysis Patients Through Waveform Analysis Using Wearable ECG
An observational study of Hyperkalemia and Chronic Kidney Disease, run by Kyungho Park at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hyperkalemia, Chronic Kidney Disease
- What is being tested?
- HiCardi wearable ECG
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2025to 28 Aug 2025
- How long will I take part?
- 6 Weeks
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged 19 years or older
- Diagnosed with chronic kidney disease (CKD) and receiving maintenance hemodialysis three times per week
- Stable clinical condition without acute complications in the past 3 months
- Ability to understand and sign informed consent
- No physical or physiological barrier to wearing an ECG device
Who cannot join
- Significant skin conditions (e.g., severe dermatitis, burns) that prevent ECG device attachment
- Refusal or inability to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hyperkalemia, Chronic Kidney Disease
- Being tested
- HiCardi wearable ECG
- Keywords
- Wearable ECG, Hemodialysis, Potassium, HiCardi
- Medical subject headings
- Hyperkalemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HiCardi wearable ECGDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemodialysis Patients | 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. Receives: Device: HiCardi wearable ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0, Week 2, Week 4, Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start23 Jun 2025
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Kyungho Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kyungho Park, Chungnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054905
- Sponsor's protocol ID
- CNUH 2025-05-023
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.