Biomarkers in Patients With Suspected HFpEF (BIOPEF)

February 10, 2024 updated by: NHS Greater Glasgow and Clyde

Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

1028

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with NT-proBNP levels taken in primary care to evaluate for suspected heart failure will be invited to participate.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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:

  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.

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:

  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.

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:

  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.

Other Names:
  • Rest echocardiography
  • Diastolic stress echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years
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 years
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.)
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

University of Glasgow
Roche Diagnostics

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2023

Primary Completion (Estimated)

September 29, 2025

Study Completion (Estimated)

September 29, 2026

Study Registration Dates

First Submitted

October 20, 2023

First Submitted That Met QC Criteria

October 20, 2023

First Posted (Actual)

October 26, 2023

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 10, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN23CA025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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