Biomarkers in Patients With Suspected Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,028
- 试验地点
- 3
- 主要终点
- Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure
研究概览
简要总结
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:
- alternative cut-offs for NT-proBNP to identify HF(pEF) in people with suspected HF and obesity
- novel candidate biomarkers to identify HF(pEF) in people with suspected HF and obesity.
- novel candidate biomarkers to identify HF(pEF) in people with suspected HF and NT-proBNP <125 ng/L
- the prevalence of HF in people with suspected HF and low NT-proBNP <125 ng/L)
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age ≥ 18 years
- •NT-proBNP sample taken by primary care physician as part of routine care for suspected heart failure
排除标准
- •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
结局指标
主要结局
Optimal cut-offs for NT-proBNP to identify HFPEF in obese patients with suspected heart failure
时间窗: 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.)
次要结局
- Utility and diagnostic performance of biomarkers (novel and adjusted stratified cut-offs) in patients with suspected HF (HFPEF, HFmREF, HFREF).(3 years)
- Optimal cut-offs for biomarkers to identify HFPEF in patients with suspected HF.(3 years)
- Prevalence of HF in patients with NT-proBNP<125ng/L(3 years)