FIND HF: Risk-guided Screening for Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 475
- 主要终点
- To determine whether detection rates of a composite of asymptomatic LVSD, HFrEF, HFmREF, or HFpEF during diagnostics are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk
研究概览
简要总结
The goal of this clinical trial is to learn if the FIND HF algorithm detection rates of heart failure during testing are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk in a population identified as at risk of undiagnosed heart failure. The main questions it aims to answer are:
- Are people who are identified as high risk by the FIND-HF tool more likely to be diagnosed with heart problems during testing than those identified as low risk?
- Are people identified as high risk by the FIND-HF tool more likely to show signs of heart problems during testing than those identified as low risk?? Researchers will compare patients in the high risk and low risk groups to see if more patients are detected with asymptomatic heart failure in the high risk group compared to the low risk group.
Participants will attend one visit at a local clinic where they will undergo an NT proBNP blood test which indicates heart failure and an echocardiogram to evaluate the heart's chambers, valves and overall function to help diagnose various heart conditions.
详细描述
Background Heart failure (HF) affects around 1-2% of adults globally and is a leading cause of unplanned hospital admissions, especially among older people. In the UK alone, over one million people have HF, with about 200,000 new cases each year. This increase is mainly due to an aging population and better survival rates following heart attacks.
From the perspective of treatment, there are three main categories of HF:
- HF with reduced ejection fraction (HFrEF)
- HF with mid-range ejection fraction (HFmrEF)
- HF with preserved ejection fraction (HFpEF) For HFrEF, four pillar therapy (diuretics, beta-blockers, angiotensin-converting enzyme inhibitors, lanoxin) is established as the gold standard for pharmacotherapeutic management, helping to reduce the risk of death and hospital admissions. For HFpEF and HFmrEF, medications like empagliflozin, dapagliflozin, and finerenone have shown promising results in reducing risks. New drugs like Semaglutide and Tirzepatide are also beneficial for HFpEF patients with obesity. There are now more treatment options for HF than ever before.
In the UK, nurse-led teams in the community are capable of initiating and adjusting HF treatments. However, diagnosing HF early, before severe symptoms appear, remains challenging. Current guidelines recommend specific tests for diagnosis, but many (8 out of 10) diagnoses are still made in hospitals, often late.
The NHS aims to improve early diagnosis in primary care to reduce hospital admissions and improve patients' quality of life.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered with a doctor practice that uses electronic health system to record patient medical notes Age at enrolment greater or equal to 40 Identified as at risk of developing Heart Failure
排除标准
- •Registered with a doctor practice that is participating in research studies relating to heart failure screening
- •Known diagnosis of HF
- •On the palliative care register
- •Unable to give written informed consent for participation in the study
- •Unable to adhere to the study requirements
研究组 & 干预措施
Patients at risk of developing Heart Failure
Patients will attend one visit with a Cardiology specialist Clinical research fellow who will carry out tests to detect Heart Failure
干预措施: FIND HF algorithm (Diagnostic Test)
结局指标
主要结局
To determine whether detection rates of a composite of asymptomatic LVSD, HFrEF, HFmREF, or HFpEF during diagnostics are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk
时间窗: Through study completion, an average of 12 months from date of enrolment
Odds ratio of asymptomatic LVSD, HFrEF, HFmREF, or HFpEF detection rates from intervention in people identified as high HF risk compared with people identified as low HF risk
次要结局
- To determine if components of composite outcome during diagnostics are higher amongst participants identified as high FIND-HF risk compared to those identified as low risk(Through study completion, an average of 12 months from date of enrolment)
研究者
Prof Christopher Gale
Professor of Cardiovascular Medicine
University of Leeds