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Biomarkers in Patients With Suspected HFpEF

Sponsor: NHS Greater Glasgow and Clyde

NCT ID: NCT06101693

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Plasma biomarker levels (diagnostic test)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
Plasma biomarker levels — diagnostic test: This study will investigate the diagnostic utility and performance of: 1.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
1,028
Started
2023-02-02
Last checked
2024-02

Plain English Summary

What is this study?

  • • Testing a new treatment for heart failure
  • • Clinical study - 1,028 participants
  • • NT-proBNP does not adequately identify HF(pEF) in people with suspected HF at low levels, particularly in patients with obesity

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with heart failure

Where?

  • • Glasgow - Glasgow Royal Infirmary
  • • Glasgow - New Victoria Hospital
  • • Glasgow - Queen Elizabeth University Hospital

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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)

More detail

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.

Heart FailureObesityHeart Failure With Preserved Ejection Fraction

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Written agreement to take part
  • ✓Age ≥ 18 years
  • ✓NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure

Who cannot take part

  • ✗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
See the full criteria
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

Where Is This Study? (3 UK sites)

Glasgow Royal Infirmary

Glasgow G128TA, United Kingdom

Recruiting
Site contact (verified)
Alice Brennan, MBChBAOalice.brennan@glasgow.ac.uk

New Victoria Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Alice Brennan, MBChBAOalice.brennan@glasgow.ac.uk

Queen Elizabeth University Hospital

Glasgow G51 4TF, United Kingdom

Recruiting
Site contact (verified)
Alice Brennan, MBChBAOalice.brennan@glasgow.ac.uk

How to Get in Touch

Ross Campbell, MBChB

Sponsor contact

CONTACT

01413302418 ross.campbell@glasgow.ac.uk

Mark Petrie, MBChB

Sponsor contact

CONTACT

0141 330 2427 mark.petrie@glasgow.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-02