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Heart Failure,CongestiveNCT05177081

Home BIA Management System in Patients With Heart Failure

A study testing Preemptive management using home BIA monitoring system in people with Heart Failure,Congestive, run by Korea University Guro Hospital at 2 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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 more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Heart Failure,Congestive
What is being tested?
Preemptive management using home BIA monitoring system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesSouth Korea
Study dates
23 Aug 2021to Dec 2022
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Eung Ju Kim, MD, PhD contact

82-2-26263022

withnoel@empas.com

Min Gyu Kong, MD contact

82-31-621-6727

mingyu.kong@gmail.com

South Korea2 sites, 2 recruiting
  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 14584

    Min Gyu Kong, MD, 82-31-621-6727, mingyu.kong@gmail.com

    Recruiting
  • Korea University Guro Hospital

    Seoul, 08308

    Eung Ju Kim, MD, PhD, 82-2-2626-3022, withnoel@empas.com

    Recruiting

Other trials in South Korea

About this study

Official title: Feasibility of Treatment Using Home Bioelectrical Impedance Analysis and Linked Application System in Patients With Heart Failure: A Multicenter Study

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.

Being tested
Preemptive management using home BIA monitoring system
Keywords
Heart failure, Bioelectrical impedance analysis
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT05177081
Study groupRoleWhat they receive
Home BIA Monitoring groupExperimentalPreemptive management by Body fluid monitoring system (BWA ON + App + Web)
Receives: Device: Preemptive management using home BIA monitoring system
Control groupNo interventionUsual heart failure management (Outpatient follow-up and medical treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in NT-proBNP

    NT-proBNP

    Measured: 3 months

Secondary outcomes (4)
  1. Rate of heart failure hospitalizations (HHF)

    Hospitalization for heart failure

    Measured: 3 months

  2. Change from baseline in edema index using BIA

    Edema index by BIA

    Measured: 3 months

  3. Change from baseline in Creatinine

    Creatinine

    Measured: 3 months

  4. Change from baseline in symptom of dyspnea

    NYHA classification and VAS scale of dyspnea

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2022
  2. Study start23 Aug 2021
  3. Primary completionDec 2022 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
multi-center, open label, randomized trial
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05177081
Sponsor's protocol ID
BWA ON Pilot
Status last verified
Jan 2022
First submitted
3 Jan 2022
Last updated
4 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Preemptive management using home BIA monitoring system in people with Heart Failure,Congestive, run by Korea University Guro Hospital at 2 sites 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 7 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 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 Eung Ju Kim, MD, PhD (82-2-26263022, withnoel@empas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in NT-proBNP (time frame: 3 months). 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 4 Jan 2022.

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