Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age \>18 years

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

• Able and willing to consent.

Locations
Other Locations
United Kingdom
Basildon University Hospital
RECRUITING
Basildon
Contact Information
Primary
Henry Oluwasefunmi Savage, MD FRCP
henry.savage@nhs.net
+44 01268524900
Backup
Archana Ganapathy, MRCP
archana.ganapathy@nhs.net
+44 01268524900
Time Frame
Start Date: 2024-12-30
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 255
Treatments
Active_comparator: BIA-guided group
Bioimpedance Analysis (BIA) will be performed within 24 hours of admission using the portable Bioscan touch i8 device (Maltron International, Essex, UK). The clinical team managing the patient will conduct serial BIA measurements and record the estimated dry weight in the patient's medical record during admission. Diuretic therapy and other fluid management strategies will be adjusted based on the BIA estimated dry weight throughout the hospital episode, in addition to standard clinical assessments, including physical examination and conventional diagnostic tools (e.g., chest X-ray, echocardiography), to achieve euvolaemia.
No_intervention: Standard Care Group
A member of the research team not involved in the patients care will conduct the BIA and will record the estimated dry weight in the research records at enrolment (BIA 1) and at discharge (BIA 2). These results would be blinded to clinicians managing the patient, who will aim to achieve euvolemia based on usual clinical judgement, discretion and conventional diagnostic tools.
Related Therapeutic Areas
Sponsors
Collaborators: Anglia Ruskin University
Leads: Mid and South Essex NHS Foundation Trust

This content was sourced from clinicaltrials.gov