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BIOPEF: Biomarkers in Patients With Suspected HFpEF

Sponsor
NHS Greater Glasgow and Clyde (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06101693
Collaborator
University of Glasgow (Other), Roche Diagnostics (Industry)
1,028
Enrollment
3
Locations
34.9
Anticipated Duration (Months)
342.7
Patients Per Site
9.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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)

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Plasma biomarker levels

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1028 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Sep 29, 2025
Anticipated Study Completion Date :
Sep 29, 2026

Arms and Interventions

Arm Intervention/Treatment
Patients with NTproBNP<125ng/L and clinical suspicion of heart failure in primary care

Expected recruitment of 400 patients (50-60% expected prevalence of obesity, according to population study)

Diagnostic Test: Plasma biomarker levels
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

    		•
    Patients with NTproBNP125-399ng/L and clinical suspicion of heart failure in primary care

    Expected recruitment of 400 patients (50% expected prevalence of obesity, according to population study)

    Diagnostic Test: Plasma biomarker levels
    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

    		•
    Patients with NTproBNP≥400ng/L and clinical suspicion of heart failure in primary care

    Expected recruitment of 400 patients (50% expected prevalence of obesity, according to population study)

    Diagnostic Test: Plasma biomarker levels
    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

    		•

    Outcome Measures

    Primary Outcome Measures

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

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Glasgow Royal Infirmary Glasgow United Kingdom G128TA
    2 New Victoria Hospital Glasgow United Kingdom G51 4TF
    3 Queen Elizabeth University Hospital Glasgow United Kingdom G51 4TF

    Sponsors and Collaborators

    • NHS Greater Glasgow and Clyde
    • University of Glasgow
    • Roche Diagnostics

    Investigators

    • Principal Investigator: Ross Campbell, MBChB, University of Glasgow

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    NHS Greater Glasgow and Clyde
    ClinicalTrials.gov Identifier:
    NCT06101693
    Other Study ID Numbers:
    • GN23CA025
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Oct 26, 2023