Clinical trial

Biomarkers in Patients With Suspected HFpEF

Recruiting now · Not applicable · 1 countries · Registry ID NCT06101693

Recruiting nowNot applicableObservational

What this study is about

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)

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

ConditionHeart Failure, Obesity, Heart Failure With Preserved Ejection Fraction

Full registry criteria

Inclusion Criteria: * Written informed consent * Age ≥ 18 years * NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure Exclusion Criteria: * Unable to consent to inclusion in study due to significant cognitive impairment * Geographical/ social reasons preventing attending study centre * Unable to complete study assessments * Patients presenting with acute HF or a previous diagnosis of HF

Treatments and study arms

Plasma biomarker levels

Diagnostic Test

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.

Primary outcomes

Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure3 years

To determine the utility and diagnostic performance of alternative cut-offs for NT-proBNP or combinations of biomarkers (including novel biomarker solutions)- with clinical variables to identify HFpEF in obese patients with suspected heart failure. (New biomarkers will be used for observational purposes only.)