Monitoring heart health in hemodialysis patients using Hativ® ECG technology
A Prospective, Multi-center Registry to Evaluate Safety and Efficacy of Hativ® ELectrocardiogram Monitoring on Patients with Hemodialysis
This study is testing a new heart monitoring device to see if it can help people on hemodialysis for kidney disease catch heart problems early and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Hallym University Medical Center Academic / other |
| Locations | 1 site (Anyang) |
| Trial ID | NCT06688565 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Hativ®, an AI-based electrocardiogram monitoring device, for patients undergoing hemodialysis due to end-stage kidney disease. Patients will use the device to record ECGs daily at home, as well as before and after dialysis sessions, and during any episodes of chest discomfort. The goal is to assess how effectively this technology can identify cardiovascular issues in this high-risk population. The study aims to improve patient outcomes by providing continuous heart monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults over 19 years old who have been on maintenance hemodialysis for more than 3 months and own a smartphone.
Not a fit: Patients with intracardiac electrodes or devices will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of cardiovascular problems in hemodialysis patients, potentially reducing mortality rates.
How similar studies have performed: While the use of AI in ECG monitoring is a growing field, this specific application in hemodialysis patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with smartphones * patients over the age of 19 who * patients receiving maintenance hemodialysis for more than 3 months due to ESRD Exclusion Criteria: * those with intracardiac electrodes and devices
Where this trial is running
Anyang
- Hallym University Sacred Heart Hospital — Anyang, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jung Nam An
- Email: lovingjn@gmail.com
- Phone: 82-10-4459-9511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.