Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure (BIO-CONGEST)

June 10, 2024 updated by: NHS Greater Glasgow and Clyde

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Heart failure (HF) is a common condition that is associated with recurrent and prolonged hospital admissions (hospitalisation). HF hospitalisation is associated with poor outcomes and therefore the identification of patients at risk of HF hospitalisation, and avoidance of these events, is of great importance.

HF hospitalisations are frequently preceded by a period of increasing congestion (pressure elevation within heart chambers and excess body fluid). The identification of congestion can be difficult. Current tests have limitations and signs of congestion such as lung crackles or leg swelling that can be recognised by health care professionals are often seen at a late stage before an intervention can be made to prevent hospitalisation. Reliably identifying congestion prior to the development of these signs would facilitate earlier intervention (treatment to de-congest) and may prevent hospitalisations. Patients who do require hospital admission are often discharged with residual congestion which is associated with readmission and increased risk of death. Tests that correlate closely with the degree of congestion and track with decongestion could guide therapy and help with decision-making about suitability for hospital discharge.

The investigators propose to recruit 140 patients. Patients will be identified during hospitalisation with HF or prior to implantation of a cardiac resynchronisation therapy (CRT) device. Each patient will have a history, physical examination, electrocardiogram (ECG), echocardiogram (cardiac ultrasound) and lung ultrasound performed. Some patients will have a procedure to record pressure measurements within the heart (right heart catheterisation) if clinically indicated as routine care. Blood and urine tests will also be taken.

The aim of this study is to evaluate the accuracy of novel blood and urine tests at measuring congestion compared with standard assessments. This may help in the discovery and development of new and improved tests for assessing congestion.

Study Type

Observational

Enrollment (Estimated)

140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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).
    • Hospitalised for the management of HF or outpatients.
    • Undergoing clinically-indicated RHC or repeat clinically-indicated RHC.

  • Cohort B

    • Meet ESC criteria for diagnosis of HFrEF.
    • Undergoing implantation of CRT device and a simultaneous clinically-indicated RHC.

  • Cohort C

    • Meet ESC criteria for diagnosis of HF, including HFrEF, HFmrEF, HFpEF.
    • Requiring treatment with IV diuretics.

Exclusion Criteria:

  • 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).
  • Pregnancy or breast-feeding (cohorts A + B where applicable).
  • Currently uncontrolled cardiac arrhythmia.
  • Severe aortic valvular disease.
  • Increased body mass index where satisfactory echocardiographic images are not possible.
  • Conditions that may confound congestion assessments in the opinion of the investigator, including: severe obstructive lung disease, severe fibrotic lung disease, severe liver disease, relevant active malignancy including lung cancer, pelvic cancer with caval compression, superior vena cava (SVC) obstruction syndrome, active viral or bacterial bronchopneumonia - chest x-ray (CXR) within four weeks showing consolidation, pulmonary contusion, pneumothorax, pneumonectomy, lobectomy, pulmonary embolism within the previous three months, indwelling intercostal chest drain, left ventricular assist device (LVAD), COVID-19 infection, type-1 acute myocardial infarction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Diagnostic test: Urine and circulating blood biomarkers
Urine and circulating blood biomarkers in all cohorts
Cohort B
Patients with HF undergoing RHC during implantation of a cardiac resynchronisation therapy (CRT) device.
Diagnostic test: Urine and circulating blood biomarkers
Urine and circulating blood biomarkers in all cohorts
Cohort C
Patients hospitalised with HF receiving intravenous (IV) diuretic therapy.
Diagnostic test: Urine and circulating blood biomarkers
Urine and circulating blood biomarkers in all cohorts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between concentrations of circulating biomarkers of congestion and pulmonary capillary wedge pressure (PCWP) and right atrial pressure (RAP).
Time Frame: 18 months
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)
Time Frame: 18 months
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.
Time Frame: 18 months
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

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 18 months
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.
Time Frame: 18 months
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).
Time Frame: 18 months
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).
Time Frame: 18 months
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.
Time Frame: 18 months
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.
Time Frame: 18 months
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.
Time Frame: 18 months
Cohort A/B: to determine the correlation between congestion measured by LUS and PCWP and RAP.
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between concentrations of circulating biomarkers of congestion and measures derived from RHC: right ventricle (RV) pressure, pulmonary artery (PA) pressure.
Time Frame: 18 months
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).
Time Frame: 18 months

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.
Time Frame: 18 months

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow
Roche Diagnostics GmbH

Investigators

  • Principal Investigator: Kieran F Docherty, MBChB, PhD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN23CA095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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