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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (3 UK sites)
Glasgow Royal Infirmary
Glasgow G128TA, United Kingdom
New Victoria Hospital
Glasgow G51 4TF, United Kingdom
Queen Elizabeth University Hospital
Glasgow G51 4TF, United Kingdom
How to Get in Touch
Ross Campbell, MBChB
Sponsor contactCONTACT
Mark Petrie, MBChB
Sponsor contactCONTACT
