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Status unknownNCT05177081Updated Jan 4, 2022

Home BIA Management System in Patients With Heart Failure

An interventional study of Preemptive management using home BIA monitoring system in Heart Failure,Congestive, sponsored by Korea University Guro Hospital. Status unknown at 2 sites in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-01-04.

Sponsored by Korea University Guro Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2021, registered Jan 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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).

Read the detailed description

The prevalence of HF is generally estimated at 1% to 2% of the general population. The more concerning thing is that HF patients are rapidly increasing due to an increase of elderly population derived from life extension; an increase in the number of survivors of heart disease due to the development of medical technology; and an increase in risk factors for HF such as obesity, diabetes, and ischemic heart disease.

HF is known that a quarter of HF patients are readmitted within 1 year, and the mortality rate within 5 years is about 50%. HF is a chronic condition, punctuated by acute decompensated episodes. Each acute decompensated event results in further organ damage: myocardial and renal damage occurring during such episodes may contribute to progressive left ventricular and/or renal dysfunction. Increasing frequency of acute events with disease progression leads to higher rates of hospitalization and increased risk of mortality.

The main symptoms of HF are shortness of breath and swelling, which are the main reasons for visiting the emergency room and hospitalization. After discharge, body water monitoring and management of HF patients are very important to prevent HF aggravation and re-hospitalization.

There are several methods of body fluid monitoring in HF patients. Current guidelines of heart failure recommends monitoring of pulmonary artery pressures using a wireless implantable hemodynamic monitoring system in symptomatic HF patients with previous HF hospitalization. Multi-parameter monitoring based on ICD is also recommended in order to improve clinical outcomes in HF patients. However, existing HF monitoring and management systems have limitations of its invasiveness, expensive costs and a lot of medical providers' efforts. Other body water monitoring methods are signs and symptoms monitoring and body weight-based monitoring. However, signs such as weight gain and edema or symptoms like dyspnea due to worsening heart failure were not recognized until just 7 and 3 days before the hospitalization event.

BIA, Bioelectrical impedance analysis can be a novel option for body water monitoring method in HF patients. Nowadays, it is possible to obtain more accurate body water by reflecting both intracellular and extracellular water by using multiple frequencies, and it is possible to accurately measure body water even in patients with unusual body water conditions such as heart failure status. Moreover, the changes of Bioelectrical Impedance are detected about two weeks before heart failure hospitalization. It is the key benefit for congestion monitoring and management.

Previous studies have shown that monitoring body water through non-invasive bioelectrical impedance can predict the worsening of HF even in patients with heart failure. In addition, there are studies that reported improvement of clinical results during treatment based on the edema index (extracellular water / total body water) during body water monitoring through non-invasive bioelectrical impedance.

Home BIA monitoring using BWA-ON has potential benefit for continuous water monitoring for edema control in patients with HF. Therefore, we aim to evaluate feasibility of treatment using home BIA and linked application system in patients with heart failure.

02

Conditions studied

  • Heart Failure,Congestive

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Keywords

  • Heart failure
  • Bioelectrical impedance analysis
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's planned enrollment of 40 is below the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients diagnosed heart failure
  2. Patients taking loop diuretics for HF symptom control
  3. Patients who can use a smart-phone

Exclusion criteria

Exclusion Criteria:

  1. Patients with implanted devices that could interfere with the BIA such as ICD and CRT
  2. Patients with limb defects
  3. Patients who unable to stand alone
  4. Patients who are pregnant
  5. Patients with End-stage renal disease (ESRD) on hemodialysis, serum creatinine of more than 5mg/dL, or nephritic syndrome
  6. Patients with systemic diseases such as hypothyroidism, decompensated liver cirrhosis, and systemic lupus erythematosus.
  7. Patients with active cellulitis, severe varicose vein, deep vein thrombosis or lymphedema
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Home BIA Monitoring group

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

    Device: Preemptive management using home BIA monitoring system

  • No intervention
    Control group

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

Interventions

  • DevicePreemptive management using home BIA monitoring system

    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.

06

What researchers measure

Primary outcomes

  1. Change from baseline in NT-proBNP

    NT-proBNP

    Time frame: 3 months

Secondary outcomes

  1. Rate of heart failure hospitalizations (HHF)

    Hospitalization for heart failure

    Time frame: 3 months

  2. Change from baseline in edema index using BIA

    Edema index by BIA

    Time frame: 3 months

  3. Change from baseline in Creatinine

    Creatinine

    Time frame: 3 months

  4. Change from baseline in symptom of dyspnea

    NYHA classification and VAS scale of dyspnea

    Time frame: 3 months

07

Study locations

2 of 2 sites recruiting
  • Soonchunhyang University Bucheon Hospital
    Bucheon-si, Gyeonggi-do 14584, Korea, Republic of
    Recruiting
  • Korea University Guro Hospital
    Seoul, 08308, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05177081
Lead sponsor
Korea University Guro Hospital
Collaborators
Soonchunhyang University Hospital
Responsible party
Eung Ju Kim (Professor, Korea University Guro Hospital) — Principal investigator
First posted
Jan 4, 2022
Start date
Aug 23, 2021
Primary completion
Dec 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
Jan 4, 2022

Study contacts

Eung Ju Kim, MD, PhD
Contact
withnoel@empas.com
82-2-26263022
Min Gyu Kong, MD
Contact
mingyu.kong@gmail.com
82-31-621-6727
Eung Ju Kim, MD, PhD
principal investigator · Korea University Guro Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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