Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMid and South Essex NHS Foundation Trust

About this trial

The goal of this clinical trial is to test whether using Bioimpedance Analysis (BIA) can help manage fluid levels in patients with heart failure who are admitted to the hospital with worsening symptoms. The main questions it aims to answer are:

1\. Does BIA-guided fluid management reduce the need for extra treatment (in the form of diuretics which helps remove excess fluid from the body) or re-hospitalization for heart failure within 90 days after discharge?

Researchers will compare a group receiving BIA-guided treatment to a standard care group to see if BIA provides better results in managing fluid levels.

Participants will be randomly assigned to one of two groups:

BIA-Guided Treatment Group: Have BIA measurements done within 24 hours of admission and throughout their hospital stay to guide diuretic treatment.

Standard Care Group: Have BIA measurements taken at admission and discharge, but the results will not be shared with the clinical team, who will manage fluid levels as usual.

All patients will attend a follow-up visit in 2-4 weeks after discharge where the patient will undergo standard health checks, blood tests, and a questionnaire about how heart failure affects their quality of life.

The investigators will then 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.

Eligibility criteria

Qualifiers

Age >18 years

Patients with hospitalised with a decompensated episode of Heart Failure regardless of Ejection Fraction

Able and willing to consent.

Disqualifiers

Patients on a palliative care pathway and/or estimated life expectancy <3 months

Patients admitted to ITU/ on intensive care support.

Patients currently taking part in any trials investigating new heart failure drug or interventional treatment.

Patients requiring Renal Replacement Therapy.

Trial design

Treatments tested in this trial

  • Bioimpedance analysis

Treatment groups

255 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mid and South Essex NHS Foundation Trust

Lead sponsor

Anglia Ruskin University

Collaborator