BIO-HF
Research type
Research Study
Full title
Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure (BIO-HF)
IRAS ID
347894
Contact name
Henry Oluwasefunmi Savage
Contact email
Sponsor organisation
Basildon Hospital, Mid and South Eseex NHS Foundation Triust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 24 months, days
Research summary
In the United Kingdom, up to 1 million people live with Heart Failure (HF) which is associated with a poor quality of life and survival. The principal presentation requiring a hospital admission is fluid congestion. Accurately monitoring a patient’s fluid status is therefore crucial in their management. Traditional methods of fluid assessment, such as physical examination, clinical judgement and imaging, have poor correlation with congestion levels. Other medical problems a patient may have such as obesity and kidney disease, may make this even more challenging. Research studies have shown that inaccurate estimations of patient’s fluid status lead to premature discharge from hospital, before patients are thoroughly decongested, leading to early rehospitalisation and poorer outcomes.
Bioimpedance Analysis (BIA) has emerged as a promising non-invasive method for assessing body composition and fluid status, providing detailed insights into total body water and fluid distribution. It could therefore offer more accurate fluid assessment while managing HF patients. It is a simple measurement obtained by attaching electrodes to the external surface of the arms and legs, similar to an ECG, connected to a computer which then calculates the excess fluid a patient may be carrying. It takes around 2 minutes to complete. This study aims to determine if a strategy of managing HF inpatients using BIA, would result in better outcomes compared to standard methods.
It is designed as a single-centre, single-blind, randomized controlled trial to evaluate the effectiveness of BIA in guiding fluid management for patients hospitalized with Acute Decompensated Heart Failure (ADHF). We intend to recruit 255 consecutive patients admitted to hospital with ADHF, randomly assigned to either a BIA-guided or standard treatment group. We will compare both groups for the primary outcome measure, which is the rates of rehospitalisation or need for additional decongestive treatment, within 90 days of discharge from hospital.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0221
Date of REC Opinion
5 Nov 2024
REC opinion
Further Information Favourable Opinion