End-Stage Kidney DiseaseNCT06688565
A Prospective, Multi-center Registry to Evaluate Safety and Efficacy of Hativ® ELectrocardiogram Monitoring on Patients with Hemodialysis
A study testing Hativ® electrocardiogram monitoring in people with End-Stage Kidney Disease and Hemodialysis, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The high mortality rate and costs of patients with end-stage renal disease (ESRD) are a medical and socio-economic burden, so managing their risk factors is very important. Recently, artificial intelligence (AI)-based electrocardiogram (ECG) analysis technology has made it possible to detect cardiovascular diseases… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- End-Stage Kidney Disease, Hemodialysis
- What is being tested?
- Hativ® electrocardiogram monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 May 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with smartphones
- patients over the age of 19 who
- patients receiving maintenance hemodialysis for more than 3 months due to ESRD
Who cannot join
- those with intracardiac electrodes and devices
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hallym University Sacred Heart Hospital
Anyang
Jung Nam An, 821044599511, lovingjn@gmail.com
About this study
The high mortality rate and costs of patients with end-stage renal disease (ESRD) are a medical and socio-economic burden, so managing their risk factors is very important. Recently, artificial intelligence (AI)-based electrocardiogram (ECG) analysis technology has made it possible to detect cardiovascular diseases using only ECGs by distinguishing minute differences in electrical currents in the heart that are difficult for humans to read, and active verification of its clinical effectiveness is in progress.
In this study, using Hativ®, a currently commercially available class II medical device, ECGs are measured every day at home and before and after dialysis. Additionally, ECGs are measured when chest discomfort or unusual symptoms were present, and the corresponding symptoms are monitored. It targets patients with smartphones over the age of 19 who are receiving maintenance hemodialysis for more than 3 months due to ESRD and excludes those with intracardiac electrodes and devices. Demographic characteristics, medications, blood tests, and echocardiography results are collected, and the results of additional questionnaires or cardiac tests are monitored for up to 3 months. During the study period, if there are any critical abnormalities or symptoms on the ECGs, the medical staff or the subject may request additional treatment.
In conclusion, by measuring ECGs before and after hemodialysis, the investigators aim to obtain data on the frequency and type of arrhythmia, confirm the relationship between cardiovascular disease and dialysis intervals. The investigators will also apply an AI-based ECG analysis model to the measured ECGs to determine the association with the mortality rate. Furthermore, the investigators plan to establish a basis for using AI analysis technology combined with a portable ECG device in the management of patients with ESRD and conduct follow-up research to improve prognosis.
- Conditions
- End-Stage Kidney Disease, Hemodialysis
- Being tested
- Hativ® electrocardiogram monitoring
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hativ® electrocardiogram monitoringDevice
Using Hativ®, a currently commercially available class II medical device, ECGs are measured every day at home and before and after dialysis
| Study group | Role | What they receive |
|---|---|---|
| Hativ® application | Experimental | Not described Receives: Device: Hativ® electrocardiogram monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of arrhythmia
Measured: 1 month
Numeric value of electrocardiogram
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start13 May 2024
- Primary completion13 May 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Kidney DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Nam An, Hallym University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688565
- Sponsor's protocol ID
- HELP-H
- Status last verified
- Jan 2024
- First submitted
- 12 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center Registry to Evaluate Safety and Efficacy of Hativ® ELectrocardiogram Monitoring on Patients with Hemodialysis
- ClinicalTrials.gov ID
- NCT06688565
- Acronym / sponsor ID
- HELP-H
- Conditions
- End-Stage Kidney Disease, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- 13 May 2024 (actual)
- Primary completion
- 13 May 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The high mortality rate and costs of patients with end-stage renal disease (ESRD) are a medical and socio-economic burden, so managing their risk factors is very important. Recently, artificial intelligence (AI)-based electrocardiogram (ECG) analysis technology has made it possible to detect cardiovascular diseases using only ECGs by distinguishing minute differences in electrical currents in the heart that are difficult for humans to read, and active verification of its clinical effectiveness is in progress.
In this study, using Hativ®, a currently commercially available class II medical device, ECGs are measured every day at home and before and after dialysis. Additionally, ECGs are measured when chest discomfort or unusual symptoms were present, and the corresponding symptoms are monitored. It targets patients with smartphones over the age of 19 who are receiving maintenance hemodialysis for more than 3 months due to ESRD and excludes those with intracardiac electrodes and devices. Demographic characteristics, medications, blood tests, and echocardiography results are collected, and the results of additional questionnaires or cardiac tests are monitored for up to 3 months. During the study period, if there are any critical abnormalities or symptoms on the ECGs, the medical staff or the subject may request additional treatment.
In conclusion, by measuring ECGs before and after hemodialysis, the investigators aim to obtain data on the frequency and type of arrhythmia, confirm the relationship between cardiovascular disease and dialysis intervals. The investigators will also apply an AI-based ECG analysis model to the measured ECGs to determine the association with the mortality rate. Furthermore, the investigators plan to establish a basis for using AI analysis technology combined with a portable ECG device in the management of patients with ESRD and conduct follow-up research to improve prognosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hativ® application | Experimental | Device: Hativ® electrocardiogram monitoring |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- patients with smartphones
- patients over the age of 19 who
- patients receiving maintenance hemodialysis for more than 3 months due to ESRD
Key exclusion criteria (1 listed)
- those with intracardiac electrodes and devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hativ® electrocardiogram monitoringUsing Hativ®, a currently commercially available class II medical device, ECGs are measured every day at home and before and after dialysis | Device | Hativ® application |
Primary outcome
Incidence of arrhythmia
Time frame: 1 month
Numeric value of electrocardiogram
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hativ® electrocardiogram monitoring in people with End-Stage Kidney Disease and Hemodialysis, run by Hallym University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Nam An (82-10-4459-9511, lovingjn@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of arrhythmia (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.