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

UnknownN/A

Sponsor: NHS Greater Glasgow and Clyde

Conditions: Heart Failure, Congestion

Interventions: Urine and circulating blood biomarkers

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (2)

Clydebank, United Kingdom
Glasgow, United Kingdom