NCT07173426 Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure
| NCT ID | NCT07173426 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mid and South Essex NHS Foundation Trust |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 255 participants |
| Start Date | 2024-12-30 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 255 participants in total. It began in 2024-12-30 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Age \>18 years 2. Patients with hospitalised with a decompensated episode of Heart Failure regardless of Ejection Fraction 3. Able and willing to consent. Exclusion Criteria: 1. Patients on a palliative care pathway and/or estimated life expectancy \<3 months 2. Patients admitted to ITU/ on intensive care support. 3. Patients currently taking part in any trials investigating new heart failure drug or interventional treatment. 4. Patients requiring Renal Replacement Therapy. 5. Patients unable or unwilling to give consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07173426 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07173426 currently recruiting?
Yes, NCT07173426 is actively recruiting participants. Contact the research team at henry.savage@nhs.net for enrollment information.
Where is the NCT07173426 trial being conducted?
This trial is being conducted at Basildon, United Kingdom.
Who is sponsoring the NCT07173426 clinical trial?
NCT07173426 is sponsored by Mid and South Essex NHS Foundation Trust. The trial plans to enroll 255 participants.
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