A Prospective, Multi-center Registry to Evaluate Safety and Efficacy of Hativ® ELectrocardiogram Monitoring on Patients with Hemodialysis

NCT06688565 | Unknown DMC

• 1 other identifier: HELP-H
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (2)

• Incidence of arrhythmia

  1 month

• Numeric value of electrocardiogram

  1 month

Study Arms (1)

Hativ® application

EXPERIMENTAL

Device: Hativ® electrocardiogram monitoring

Interventions

Hativ® electrocardiogram monitoring DEVICE

Using Hativ®, a currently commercially available class II medical device, ECGs are measured every day at home and before and after dialysis

Hativ® application

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients with smartphones
• patients over the age of 19 who
• patients receiving maintenance hemodialysis for more than 3 months due to ESRD

You may not qualify if:

• those with intracardiac electrodes and devices

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang, South Korea

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jung Nam An

CONTACT

82-10-4459-9511; lovingjn@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: May 13, 2024
• Primary Completion: May 13, 2025
• Study Completion: December 31, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-01

Locations

KR (1)