Bioimpedance Integration for Optimized Fluid Management in Decompensated Heart Failure

NCT07173426 | Recruiting

• 1 other identifier: 347894
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Decompensated Heart Failure

Keywords

Bioimpedance Analysis; Decompensated Heart Failure; Fluid Assessment

Outcome Measures

Primary Outcomes (1)

• Heart Failure Event within 90 days post discharge

  This is defined as outpatient requirement to increase oral diuretics or hospitalization for intravenous diuretics due to decompensated heart failure.

  90 days post discharge

Secondary Outcomes (8)

• Evidence of Acute Kidney Injury

  At any time from hospitalisation till follow-up in Outpatient clinic 2-4 weeks after discharge

• Hospital Length of stay

  30 days

• NT pro-BNP after discharge from hospital

  2-4 weeks after discharge from hospital

• Patient Reported outcomes after discharge from hospital

  2-4 weeks post discharge

• All-cause Hospitalisation at 3months

  90 days

Study Arms (2)

BIA-guided group

ACTIVE COMPARATOR

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.

Device: Bioimpedance analysis

Standard Care Group

NO INTERVENTION

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.

Interventions

Bioimpedance analysis DEVICE

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.

BIA-guided group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patients with hospitalised with a decompensated episode of Heart Failure regardless of Ejection Fraction
• Able and willing to consent.

You may not qualify if:

• 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.
• Patients unable or unwilling to give consent.

Sponsors & Collaborators

• Mid and South Essex NHS Foundation Trust: lead
• Anglia Ruskin University: collaborator

Study Sites (1)

Basildon University Hospital

Basildon, Essex, SS16 5NL, United Kingdom

RECRUITING

Related Publications (11)

• Santarelli S, Russo V, Lalle I, De Berardinis B, Vetrone F, Magrini L, Di Stasio E, Piccoli A, Codognotto M, Mion MM, Castello LM, Avanzi GC, Di Somma S; GREAT network. Prognostic value of decreased peripheral congestion detected by Bioelectrical Impedance Vector Analysis (BIVA) in patients hospitalized for acute heart failure: BIVA prognostic value in acute heart failure. Eur Heart J Acute Cardiovasc Care. 2017 Jun;6(4):339-347. doi: 10.1177/2048872616641281. Epub 2016 Apr 12.

  PMID: 27073131 BACKGROUND

• Mayne KJ, Shemilt R, Keane DF, Lees JS, Mark PB, Herrington WG. Bioimpedance Indices of Fluid Overload and Cardiorenal Outcomes in Heart Failure and Chronic Kidney Disease: a Systematic Review. J Card Fail. 2022 Nov;28(11):1628-1641. doi: 10.1016/j.cardfail.2022.08.005. Epub 2022 Aug 28.

  PMID: 36038013 BACKGROUND

• Alves FD, Souza GC, Clausell N, Biolo A. Prognostic role of phase angle in hospitalized patients with acute decompensated heart failure. Clin Nutr. 2016 Dec;35(6):1530-1534. doi: 10.1016/j.clnu.2016.04.007. Epub 2016 Apr 13.

  PMID: 27118274 BACKGROUND

• Colin-Ramirez E, Castillo-Martinez L, Orea-Tejeda A, Vazquez-Duran M, Rodriguez AE, Keirns-Davis C. Bioelectrical impedance phase angle as a prognostic marker in chronic heart failure. Nutrition. 2012 Sep;28(9):901-5. doi: 10.1016/j.nut.2011.11.033. Epub 2012 Mar 30.

  PMID: 22465907 BACKGROUND

• Di Somma S, Lalle I, Magrini L, Russo V, Navarin S, Castello L, Avanzi GC, Di Stasio E, Maisel A. Additive diagnostic and prognostic value of bioelectrical impedance vector analysis (BIVA) to brain natriuretic peptide 'grey-zone' in patients with acute heart failure in the emergency department. Eur Heart J Acute Cardiovasc Care. 2014 Jun;3(2):167-75. doi: 10.1177/2048872614521756. Epub 2014 Jan 29.

  PMID: 24477201 BACKGROUND

• Di Somma S, De Berardinis B, Bongiovanni C, Marino R, Ferri E, Alfei B. Use of BNP and bioimpedance to drive therapy in heart failure patients. Congest Heart Fail. 2010 Jul;16 Suppl 1:S56-61. doi: 10.1111/j.1751-7133.2010.00162.x.

  PMID: 20653713 BACKGROUND

• Massari F, Scicchitano P, Iacoviello M, Passantino A, Guida P, Sanasi M, Piscopo A, Romito R, Valle R, Caldarola P, Ciccone MM. Multiparametric approach to congestion for predicting long-term survival in heart failure. J Cardiol. 2020 Jan;75(1):47-52. doi: 10.1016/j.jjcc.2019.05.017. Epub 2019 Jul 17.

  PMID: 31326239 BACKGROUND

• da Silva AT, Hauschild DB, de Almeida Oliveira LD, de Fragas Hinnig P, Franco Moreno YM, Wazlawik E. Association of hyperhydration evaluated by bioelectrical impedance analysis and mortality in patients with different medical conditions: Systematic review and meta-analyses. Clin Nutr ESPEN. 2018 Dec;28:12-20. doi: 10.1016/j.clnesp.2018.08.022. Epub 2018 Sep 21.

  PMID: 30390867 BACKGROUND

• Sakaguchi T, Hirata A, Kashiwase K, Higuchi Y, Ohtani T, Sakata Y, Yasumura Y. Relationship of Central Venous Pressure to Body Fluid Volume Status and Its Prognostic Implication in Patients With Acute Decompensated Heart Failure. J Card Fail. 2020 Jan;26(1):15-23. doi: 10.1016/j.cardfail.2018.06.001. Epub 2018 Jun 9.

  PMID: 29890212 BACKGROUND

• Jaffrin MY, Morel H. Body fluid volumes measurements by impedance: A review of bioimpedance spectroscopy (BIS) and bioimpedance analysis (BIA) methods. Med Eng Phys. 2008 Dec;30(10):1257-69. doi: 10.1016/j.medengphy.2008.06.009. Epub 2008 Aug 3.

  PMID: 18676172 BACKGROUND

• Sakaguchi T, Yasumura K, Nishida H, Inoue H, Furukawa T, Shinouchi K, Miura H, Miyazaki K, Hamano G, Koide M, Abe H, Date M, Hirooka K, Koretsune Y, Kusuoka H, Yasumura Y. Quantitative Assessment of Fluid Accumulation Using Bioelectrical Impedance Analysis in Patients With Acute Decompensated Heart Failure. Circ J. 2015;79(12):2616-22. doi: 10.1253/circj.CJ-15-0723. Epub 2015 Oct 16.

  PMID: 26477274 BACKGROUND

Related Links

• NICE guidance for diagnosis and management of chronic heart failure.
• National Heart Failure Audit (NHFA) by National Institute for Cardiovascular Outcomes Research

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Henry Oluwasefunmi Savage, MD FRCP

CONTACT

+44 01268524900; henry.savage@nhs.net

Archana Ganapathy, MRCP

CONTACT

+44 01268524900; archana.ganapathy@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients admitted with decompensated Heart Failure are randomly allocated into one of the 2 groups using an online number generator: BIA Guided group In the BIA-Guided Group, BIA is performed within 24 hours of admission using a portable device that measures body water distribution and provides as estimated dry weight. These results, available within 2 minutes, help clinicians adjust diuretic therapy alongside standard assessments to achieve optimal fluid balance (euvolaemia). Standard Care Group In the Standard Care Group, BIA is performed by research staff and results are blinded from the clinical team. Fluid management relies on usual clinical judgement and diagnostic tools. All participants will receive follow-up 2-4 weeks after discharge, including NTproBNP blood tests, and the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) to evaluate heart failure symptoms. The investigators will then compare the primary outcome at 90 days in both these groups.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: September 15, 2025
• Study Start: December 30, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)