Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure

ConditionsHeart Failure Congestion

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent.

Male or female ≥18 years of age.

Cohort A

Meet European Society of Cardiology (ESC) criteria for diagnosis of HF1, including HF with reduced (HFrEF), mildly reduced (HFmrEF) and preserved ejection fractions (HFpEF).

Disqualifiers

Unwilling to consent.

Unable to consent to inclusion in study due to cognitive impairment.

Previously enrolled in the BIO-CONGEST study.

Current participation in a blinded drug interventional trial (or treatment within four weeks).

Trial population

Cohort A: patients with heart failure (HF) undergoing clinically indicated right heart catheterisation (RHC) +/- clinically-indicated repeat RHC in the Scottish Advanced Heart Failure Service (SNAHFS). Cohort B: patients with HF undergoing RHC during implantation of a cardiac resynchronisation therapy (CRT) device. Cohort C: patients hospitalised with HF receiving intravenous (IV) diuretic therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Urine and circulating blood biomarkers
Diagnostic test
Urine and circulating blood biomarkers in all cohorts

Treatment groups

140 Participants

are divided into 3 treatment groups

Group A: Cohort A1 intervention

Group B: Cohort B1 intervention

Group C: Cohort C1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

18 months

Secondary outcomes

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).

Time frame

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.

Time frame

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.

Time frame

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).

Time frame

18 months

Other outcomes

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.

Time frame

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).

Time frame

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.

Time frame

18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Glasgow

Collaborator

Roche Diagnostics GmbH

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: