Heart Failure, Heart Failure With Preserved Ejection Fraction, Obesity
Conditions
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)
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.
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.
Sponsors
University of Glasgow
Roche Diagnostics GmbH
NHS Greater Glasgow and Clyde
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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.) |
Countries
United Kingdom
Contacts
Primary ContactRoss Campbell, MBChB
Backup ContactMark Petrie, MBChB
Outcome results
None listed