Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure
NCT Number: NCT06459999
Acronym: BIO-CONGEST
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Heart Failure|Congestion
Interventions: DIAGNOSTIC_TEST: Urine and circulating blood biomarkers
Sponsor: NHS Greater Glasgow and Clyde
Collaborators: University of Glasgow|Roche Diagnostics GmbH
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 140
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-06
Completion Date: 2025-12
Locations: Golden Jubilee National Hospital, Clydebank, G81 4DY, United Kingdom|Queen Elizabeth University Hospital, Glasgow, G51 4TF, United Kingdom

Summary:
The goal of this study is to test the accuracy of new blood and urine tests in people with heart failure. The main question it aims to answer is:

- Do new blood and urine tests correlate with fluid status? This will be determined by comparison to routine and gold-standard tests in a range of patients with heart failure.

Primary Outcome Measures: Correlation between concentrations of circulating biomarkers of congestion and pulmonary capillary wedge pressure (PCWP) and right atrial pressure (RAP)., Cohorts A/B - patients with heart failure (HF) undergoing right heart catheterisation (RHC): to determine the correlation between concentrations of circulating biomarkers of congestion and PCWP and RAP., 18 months|Correlation of change in congestion measured by concentrations of circulating biomarkers of congestion and change in lung ultrasound (LUS), Cohort C: to determine the correlation of change in congestion measured by concentrations of circulating biomarkers of congestion and change in LUS., 18 months|Correlation of change in congestion measured by concentrations of circulating biomarkers of congestion and change in weight., Cohort C: to determine the correlation of change in congestion measured by concentrations of circulating biomarkers of congestion and change in weight., 18 months
Secondary Outcome Measures: Correlation between congestion measured by concentrations of circulating biomarkers of congestion and physical signs (including EVEREST clinical congestion score [ECCS] and degree of pulmonary oedema)., Cohorts A/B/C: to determine the correlation between congestion measured by concentrations of circulating biomarkers of congestion and physical signs (including ECCS and degree of pulmonary oedema)., 18 months|Correlation between congestion measured by concentrations of circulating biomarkers of congestion and LUS., Cohorts A/B/C: to determine the correlation between congestion measured by concentrations of circulating biomarkers of congestion and LUS., 18 months|Correlation between congestion measured by concentrations of circulating biomarkers of congestion and transthoracic echocardiography (TTE)., Cohorts A/B/C: to determine the correlation between congestion measured by concentrations of circulating biomarkers of congestion and TTE., 18 months|Correlation of change in congestion measured by change in concentrations of circulating biomarkers and change in congestion measured by physical signs (including ECCS and degree of pulmonary oedema)., Cohort C: to determine the correlation of change in congestion measured by change in concentrations of circulating biomarkers and change in congestion measured by physical signs (including ECCS and degree of pulmonary oedema)., 18 months|Correlation of change in congestion measured by change in concentrations of circulating biomarkers and change in congestion measured by TTE., Cohort C: to determine the correlation of change in congestion measured by change in concentrations of circulating biomarkers and change in congestion measured by TTE., 18 months|Correlation between congestion measured by TTE and PCWP and RAP., Cohort A/B: to determine the correlation between congestion measured by TTE and PCWP and RAP., 18 months|Correlation between congestion measured by LUS and PCWP and RAP., Cohort A/B: to determine the correlation between congestion measured by LUS and PCWP and RAP., 18 months
Other Outcome Measures: Correlation between concentrations of circulating biomarkers of congestion and measures derived from RHC: right ventricle (RV) pressure, pulmonary artery (PA) pressure., Cohort A/B: correlation coefficient between concentrations of circulating biomarkers of congestion and measures derived from RHC: right ventricle (RV) pressure, pulmonary artery (PA) pressure., 18 months|Correlation between change in concentrations of circulating biomarkers of congestion and change in other measures of congestion (as description below)., Cohort A (in those undergoing repeat RHC): correlation coefficient between change in concentrations of circulating biomarkers of congestion and change in:

* PCWP and RAP.
* Number of B-lines on LUS.
* Weight.
* Measures derived from RHC (RV, PA pressures).
* Measures derived from TTE (including IVC size, TR Vmax and E/e').
* Physical signs of congestion (including ECCS and degree of pulmonary oedema)., 18 months|Regression analyses between frequency of rehospitalization or death and circulating biomarkers of congestion during hospital admission., Cohort C: Regression analyses between frequency of rehospitalization or death within 3 months after discharge and:

* Concentrations of circulating biomarkers of congestion from the first blood draw.
* Concentrations of circulating biomarkers of congestion from the last blood draw.
* Change in concentrations of circulating biomarkers of congestion., 18 months