Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT06101693
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2023-10-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Biomarkers in Patients With Suspected HFpEF
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
Study Overview
Official Title:
Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BIOPEF
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)
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: