RecruitingNot ApplicableNCT07173426

Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure


Sponsor

Mid and South Essex NHS Foundation Trust

Enrollment

255 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether using bioimpedance analysis — a painless, non-invasive test that measures body fluid levels using small electrical signals — to guide fluid removal in people hospitalized with heart failure leads to better outcomes compared to standard care. **You may be eligible if...** - You are over 18 years old and have been hospitalized with a flare-up (decompensation) of heart failure - You are willing and able to consent **You may NOT be eligible if...** - You are on a palliative care pathway or expected to live less than 3 months - You are in the intensive care unit or on intensive care support - You are currently enrolled in another heart failure drug trial - You require dialysis - You are unable or unwilling to give consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioimpedance 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.


Locations(1)

Basildon University Hospital

Basildon, Essex, United Kingdom

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NCT07173426


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