Heart FailureBIO-CONGESTNCT06459999
Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure
An observational study of Heart Failure and Congestion, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Congestion
- What is being tested?
- Urine and circulating blood biomarkers
- Type of treatment
- Injection or infusion
- How many people
- 140 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2024to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Daniel J Doherty, BSc, MBChB contact
United Kingdom2 sites
Golden Jubilee National Hospital
Clydebank, G81 4DY
Daniel J Doherty, BSc, MBChB, daniel.doherty@glasgow.ac.uk
Queen Elizabeth University Hospital
Glasgow, G51 4TF
Daniel J Doherty, BSc, MBChB, daniel.doherty@glasgow.ac.uk
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Congestion
- Being tested
- Urine and circulating blood biomarkers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine and circulating blood biomarkersDiagnostic test
Urine and circulating blood biomarkers in all cohorts
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Diagnostic Test: Urine and circulating blood biomarkers | |
| Cohort B | Patients with HF undergoing RHC during implantation of a cardiac resynchronisation therapy (CRT) device. Receives: Diagnostic Test: Urine and circulating blood biomarkers | |
| Cohort C | Patients hospitalised with HF receiving intravenous (IV) diuretic therapy. Receives: Diagnostic Test: Urine and circulating blood biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, Roche Diagnostics GmbH
- Responsible party
- Sponsor
- Investigators
- Kieran F Docherty, MBChB, PhD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06459999
- Sponsor's protocol ID
- GN23CA095
- Acronym
- BIO-CONGEST
- Status last verified
- Jun 2024
- First submitted
- 3 Jun 2024
- Last updated
- 14 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers for the Assessment of Congestion in Patients With Ambulatory and Hospitalised Heart Failure
- ClinicalTrials.gov ID
- NCT06459999
- Acronym / sponsor ID
- BIO-CONGEST / GN23CA095
- Conditions
- Heart Failure, Congestion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, Roche Diagnostics GmbH
- Study start
- Jun 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Diagnostic Test: Urine and circulating blood biomarkersPatients 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 | – | Diagnostic Test: Urine and circulating blood biomarkersPatients with HF undergoing RHC during implantation of a cardiac resynchronisation therapy (CRT) device. |
| Cohort C | – | Diagnostic Test: Urine and circulating blood biomarkersPatients hospitalised with HF receiving intravenous (IV) diuretic therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Written informed consent.
- Male or female ≥18 years of age.
- Cohort A
- Cohort B
- Cohort C
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine and circulating blood biomarkersUrine and circulating blood biomarkers in all cohorts | Diagnostic test | Cohort A, Cohort B, Cohort C |
Primary outcome
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.
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.
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.
7 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).
Time frame: 18 months
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).
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).
Time frame: 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
Correlation between congestion measured by TTE and PCWP and RAP.
Time frame: 18 months
Correlation between congestion measured by LUS and PCWP and RAP.
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Doherty, BSc, MBChB contact
Kieran F Docherty, MBChB, PhD principal investigator
University of Glasgow
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Congestion, run by NHS Greater Glasgow and Clyde at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kieran F Docherty, MBChB, PhD (01413301672, kieran.docherty@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between concentrations of circulating biomarkers of congestion and pulmonary capillary wedge pressure (PCWP) and right atrial pressure (RAP). (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.