NCT05177081

Brief Summary

This study is a prospective, multi-center, open label, randomized clinical trial conducted in the republic of Korea. The objective of this study is to evaluate the efficacy and safety of the treatment using home bioelectrical impedance analysis (BIA) and linked application system in patients with heart failure (HF).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 23, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

January 4, 2022

Status Verified

January 1, 2022

Enrollment Period

1.3 years

First QC Date

January 3, 2022

Last Update Submit

January 3, 2022

Conditions

Heart Failure，Congestive

Keywords

Heart failureBioelectrical impedance analysis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in NT-proBNP

    NT-proBNP

    3 months

Secondary Outcomes (4)

  • Rate of heart failure hospitalizations (HHF)

    3 months

  • Change from baseline in edema index using BIA

    3 months

  • Change from baseline in Creatinine

    3 months

  • Change from baseline in symptom of dyspnea

    3 months

Study Arms (2)

Home BIA Monitoring group

EXPERIMENTAL

Preemptive management by Body fluid monitoring system (BWA ON + App + Web)

Device: Preemptive management using home BIA monitoring system

Control group

NO INTERVENTION

Usual heart failure management (Outpatient follow-up and medical treatment)

Interventions

Preemptive management using home BIA monitoring systemDEVICE

Patients check their body composition and fluid using Home BIA system. Investigators analyze patients' body congestion status and send patient's edema status and direction of extra-diuretics usage to enrolled patients every one week.

Home BIA Monitoring group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed heart failure
  • Patients taking loop diuretics for HF symptom control
  • Patients who can use a smart-phone

You may not qualify if:

  • Patients with implanted devices that could interfere with the BIA such as ICD and CRT
  • Patients with limb defects
  • Patients who unable to stand alone
  • Patients who are pregnant
  • Patients with End-stage renal disease (ESRD) on hemodialysis, serum creatinine of more than 5mg/dL, or nephritic syndrome
  • Patients with systemic diseases such as hypothyroidism, decompensated liver cirrhosis, and systemic lupus erythematosus.
  • Patients with active cellulitis, severe varicose vein, deep vein thrombosis or lymphedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Soonchunhyang University Bucheon Hospital

Bucheon-si, Gyeonggi-do, 14584, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 08308, South Korea

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Eung Ju Kim, MD, PhD

    Korea University Guro Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eung Ju Kim, MD, PhD

CONTACT

82-2-26263022withnoel@empas.com

Min Gyu Kong, MD

CONTACT

82-31-621-6727mingyu.kong@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: multi-center, open label, randomized trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 4, 2022

Study Start

August 23, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

January 4, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(2)