Home BIA Management System in Patients With Heart Failure

Heart Failure,Congestive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05177081
• Other study ID #: BWA ON Pilot
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: December 2022

Study information

• Verified date: January 2022
• Source: Korea University Guro Hospital
• Contact: Eung Ju Kim, MD, PhD
• Phone: 82-2-26263022
• Email: withnoel[@]empas.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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:

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure,Congestive

Intervention

Device:
• Preemptive 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.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Bucheon Hospital	Bucheon-si	Gyeonggi-do
Korea, Republic of	Korea University Guro Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Korea University Guro Hospital	Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in NT-proBNP	NT-proBNP	3 months
Secondary	Rate of heart failure hospitalizations (HHF)	Hospitalization for heart failure	3 months
Secondary	Change from baseline in edema index using BIA	Edema index by BIA	3 months
Secondary	Change from baseline in Creatinine	Creatinine	3 months
Secondary	Change from baseline in symptom of dyspnea	NYHA classification and VAS scale of dyspnea	3 months