Finding Heart Failure in Those Prescribed Loop Diuretics in Primary Care in Jersey (FIND-HF LOOP)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- New Heart Failure diagnosis at 12 months
研究概览
简要总结
The goal of this clinical trial is to learn whether a simple blood test screening pathway can help diagnose heart failure earlier in adults in primary care who take loop diuretic medicines (such as furosemide or bumetanide) but do not have a recorded diagnosis of heart failure.
The main questions it aims to answer are:
- Does offering a NT-proBNP blood test to eligible patients increase the number of new heart failure diagnoses within 12 months compared with usual care?
- Does this screening pathway also uncover other important heart problems, such as irregular heart rhythms (arrhythmias) or valve disease?
This is a cluster randomised controlled trial, which means that whole GP practices, rather than individual patients, are randomly assigned to one of two approaches:
- NT-proBNP screening pathway, in which eligible patients are invited for a NT-proBNP blood test
- Usual care, in which patients continue to be managed as they normally would without proactive screening
Participants will:
Be identified from GP records if they are prescribed loop diuretics and have no prior diagnosis of heart failure
In screening practices, be invited to attend for a free finger-prick NT-proBNP blood test and brief questionnaire
Be referred to the heart failure team and invited for an echocardiogram (a heart ultrasound scan) and further assessment if their NT-proBNP level is higher than 125 pg/mL
Researchers will compare outcomes between screening and usual-care practices after 12 months, focusing on new diagnoses of heart failure. They will also look at other important cardiovascular findings, such as new arrhythmias, valve disease, and heart failure hospitalisation rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Receiving a loop diuretic (furosemide, bumetanide or torsemide)
- •No coded diagnosis of heart failure in GP records
- •Never had a natriuretic peptide test
- •Willing to have a blood test for NT-proBNP
排除标准
- •Clinical Frailty Score 7 or above on Rockwood frailty scale
- •Prior diagnosis of heart failure
- •Prior natriuretic peptide testing
研究组 & 干预措施
Intervention - NTproBNP Screening
Half of the island's GP surgeries will be randomly allocated to the intervention arm, whereby patients receiving a loop diuretic but without a diagnosis of heart failure or natriuretic peptide testing will be invited for a point of care NT-proBNP test.
干预措施: NT-proBNP screening (Diagnostic Test)
Control - Usual care
Half of the island's GP surgeries will be randomly allocated to the control arm, whereby patients will continue with usual clinical care and won't be approached by the study team.
结局指标
主要结局
New Heart Failure diagnosis at 12 months
时间窗: 12 months from practice enrollment
次要结局
- Heart Failure Hospitalisations(12 months)
- New clinically relevant cardiovascular disease(12 months)
- All cause mortality(12 months)
研究者
Aaron Henry
Cardiology Research Fellow
Government of Jersey
