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Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure

NCT07173426 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Bioimpedance analysis

Bioimpedance analysis involves electrodes attached to the patient's limbs which measures the resistance in the body to an imperceptible high-frequency, low-amplitude alternating electrical current. BIA measurements will include total body water (TBW), intracellular water (ICW), extracellular water (ECW), and the derived parameter "dry weight". Results are available at the bedside within 2 minutes.

Sponsors & Collaborators

  • Anglia Ruskin University

    collaborator OTHER

  • Mid and South Essex NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2026-05-01
Completion
2026-12-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07173426 on ClinicalTrials.gov