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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NHS Greater Glasgow and Clyde

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Glasgow
Roche Diagnostics GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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