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

Inclusion Criteria3

  • Written informed consent
  • Age ≥ 18 years
  • NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure

Exclusion Criteria4

  • 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

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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