RecruitingNCT06101693

Biomarkers in Patients With Suspected HFpEF

Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction


Sponsor

NHS Greater Glasgow and Clyde

Enrollment

1,028 participants

Start Date

Feb 2, 2023

Study Type

OBSERVATIONAL

Conditions

Summary

NT-proBNP does not adequately identify HF(pEF) in people with suspected HF at low levels, particularly in patients with obesity. This study will investigate: 1. alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity 2. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity. 3. novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L 4. the prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting blood samples and clinical data from people who are being investigated by their GP for possible heart failure — specifically a type called heart failure with preserved ejection fraction (HFpEF), where the heart pumps normally but is too stiff. Researchers want to find better blood markers that can diagnose and predict outcomes for this condition. **You may be eligible if...** - You are 18 years or older - Your primary care doctor has taken a specific blood test called NT-proBNP as part of investigating whether you might have heart failure - You are willing to give written consent and attend the study center **You may NOT be eligible if...** - You cannot give informed consent due to significant cognitive impairment - Distance or social circumstances prevent you from attending the study site - You have been previously diagnosed with heart failure - You are currently experiencing acute (sudden/severe) heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPlasma biomarker levels

This study will investigate the diagnostic utility and performance of: 1. Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom 2. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity. 3. Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP \<125 ng/L 4. The prevalence of HF in people with suspected HF and low NT-proBNP \<125 ng/L). The diagnosis of heart failure will be determined according to international guidelines, when there are symptoms and/or signs of HF in association with "objective evidence of cardiac structural and/or functional abnormalities consistent with the presence of LV diastolic dysfunction/raised LV filling pressures". Non-invasive testing with rest and diastolic stress echocardiography will be used to evaluate for evidence of raised filling pressures, in order to make the study procedures applicable to usual clinical practice.


Locations(3)

Glasgow Royal Infirmary

Glasgow, United Kingdom

New Victoria Hospital

Glasgow, United Kingdom

Queen Elizabeth University Hospital

Glasgow, United Kingdom

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NCT06101693


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