Clinical trial NCT05177081: Home BIA Management System in Patients With Heart Failure
Official title: Feasibility of Treatment Using Home Bioelectrical Impedance Analysis and Linked Application System in Patients With Heart Failure: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure，Congestive
Keywords: Heart failure
Bioelectrical impedance analysis
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
Collaborators: name: Soonchunhyang University Hospital
First posted: 2022-01-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multi-center, open label, randomized trial
Primary purpose: PREVENTION

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in NT-proBNP
timeFrame: 3 months
Secondary outcomes:
measure: Rate of heart failure hospitalizations (HHF)
timeFrame: 3 months
measure: Change from baseline in edema index using BIA
timeFrame: 3 months
measure: Change from baseline in Creatinine
timeFrame: 3 months
measure: Change from baseline in symptom of dyspnea
timeFrame: 3 months
Other outcomes:
Locations:
city: Bucheon-si
country: Korea, Republic of
facility: Soonchunhyang University Bucheon Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Eung Ju Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: