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

NCT06459999 | Not Yet Recruiting

• 1 other identifier: GN23CA095
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure; Congestion

Outcome Measures

Primary Outcomes (3)

• 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 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).

  18 months

• 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).

  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).

  18 months

• Correlation of change in congestion measured by change in concentrations of circulating biomarkers and change in congestion measured by TTE.

  18 months

Other Outcomes (3)

• Correlation 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).

  18 months

• Regression analyses between frequency of rehospitalization or death and circulating biomarkers of congestion during hospital admission.

  18 months

Study Arms (3)

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

Cohort B

Patients with HF undergoing RHC during implantation of a cardiac resynchronisation therapy (CRT) device.

Diagnostic Test: Urine and circulating blood biomarkers

Cohort C

Patients hospitalised with HF receiving intravenous (IV) diuretic therapy.

Diagnostic Test: Urine and circulating blood biomarkers

Interventions

Urine and circulating blood biomarkers DIAGNOSTIC_TEST

Urine and circulating blood biomarkers in all cohorts

Cohort A; Cohort B; Cohort C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unwilling to consent.
• 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.

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• Roche Diagnostics GmbH: collaborator

Study Sites (2)

Golden Jubilee National Hospital

Clydebank, G81 4DY, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Urination

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Kieran F Docherty, MBChB, PhD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kieran F Docherty, MBChB, PhD

CONTACT

01413301672; kieran.docherty@glasgow.ac.uk

Daniel J Doherty, BSc, MBChB

CONTACT

daniel.doherty@glasgow.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

GB (2)