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NCT Number: NCT06101693

Biomarkers in Patients With Suspected HFpEF

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)

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Key information

Conditions

Heart Failure Body Weight Cardiovascular Diseases Heart Diseases Heart Failure With Preserved Ejection Fraction Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Glasgow Royal Infirmary, Glasgow, United Kingdom

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About this study

This will be a prospective observational, non-randomised study of patients in primary care with suspected HF.

Detection of HFpEF in people without obesity is well-served by NT-proBNP. In contrast, NT-proBNP does not perform well when used to detect HFpEF in populations with obesity. There is increasing evidence that some people with low levels of NT-proBNP can have HF. As many as 50% of people with obesity and HFpEF (detected by elevated filling pressures) have NT-proBNP <125 ng/L. Some patients with HFpEF who are not obese can also have low natriuretic peptides levels.

Delayed diagnosis can lead to adverse outcomes for patients, in particular presentation acutely to secondary care. In addition to this, some patients with HFpEF who are not obese can also have low natriuretic peptides levels.

Patients with NTproBNP levels performed in the community for stable symptoms of suspected heart failure will be invited to participate.

Assessments in this study will include clinical history and examination, patient-reported outcome measures, electrocardiography, echocardiography and biomarker (blood and urine) analysis. Heart failure diagnostic scores and clinical evaluation by heart failure experts will be used to make a clinical diagnosis of heart failure, and to correlate this with levels of plasma and urine biomarkers, both established and novel.

Patients will be followed up passively (for a minimum of 10 years) using record linkage for subsequent hospitalisations or deaths.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma biomarker levels

Diagnostic Test

This study will investigate the diagnostic utility and performance of:

  • Alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity, in whom
  • Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
  • Novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP <125 ng/L
  • 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.

Other names: Rest echocardiography, Diastolic stress echocardiography

Primary outcomes

  1. Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure

    Time frame: 3 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.)

Secondary outcomes

  1. Prevalence of HF in patients with NT-proBNP<125ng/L

    Time frame: 3 years

    To identify the prevalence of HF in patients with NT-proBNP <125 ng/L with and without obesity, and suspected HF.

  2. Optimal cut-offs for biomarkers to identify HFPEF in patients with suspected HF.

    Time frame: 3 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 patients (with and without obesity) and suspected HF.

  3. Utility and diagnostic performance of biomarkers (novel and adjusted stratified cut-offs) in patients with suspected HF (HFPEF, HFmREF, HFREF).

    Time frame: 3 years

    To determine the utility and diagnostic performance of novel biomarkers, adjusted N-terminal pro-B-type natriuretic peptide (NT-proBNP) cut-offs or combinations of biomarkers with clinical variables in patients with suspected HF (HFpEF, HFmrEF, HFrEF). (New biomarkers will be used for observational purposes only.)

Study contacts

Contact information is provided by the study sponsor or research team.

Mark Petrie, MBChB

CONTACT

[email protected]

0141 330 2427

Ross Campbell, MBChB

CONTACT

[email protected]

01413302418

Sponsors and collaborators

Lead sponsor

NHS Greater Glasgow and Clyde

Other

Collaborators

  • Roche Diagnostics GmbH
  • University of Glasgow

Registry information

Official study title

Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction

Acronym: BIOPEF

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Oct 26, 2023
Registry last updated
Feb 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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