NCT06459999

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 140 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Urine and circulating blood biomarkers	Urine and circulating blood biomarkers in all cohorts

Timeline

• Start date: 2024-06-01
• Primary completion: 2025-09-01
• Completion: 2025-12-01
• First posted: 2024-06-14
• Last updated: 2024-06-14

Locations

2 sites across 1 country: United Kingdom