St. Vincent's Screening To Prevent Heart Failure (STOP-HF) Study Using Natriuretic Peptides to Identify and Prevent Progression of Left Ventricular Dysfunction in Community Based, Asymptomatic, At-risk Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,378
- 试验地点
- 1
- 主要终点
- Prevalence and severity of LVD
研究概览
简要总结
The STOP-HF study is a prospective, randomized, controlled trial recruiting asymptomatic individuals with risk factors for left ventricular dysfunction from 50 primary care clinics in Dublin and south east Ireland. It is designed to determine whether using natriuretic peptide measurement as a screening tool following a general cardiovascular risk factor screen will reduce the prevalence and severity of ventricular dysfunction in conjunction with specialist follow-up at St. Vincent's University Hospital.
详细描述
A large proportion of the population has substantial left ventricular dysfunction (LVD) and do not have symptoms (Stage B heart failure). For many of these patients, if identified and treated appropriately, it is possible to prevent the subsequent development of heart failure (HF). Although the current gold standard for detection of LVD is echocardiography, it is expensive and impractical for mass screening.
Natriuretic peptides are attractive candidates for screening populations for asymptomatic LVD particularly because of high negative predictive values. Furthermore, some studies have shown that, in the right setting, screening with natriuretic peptides might prove cost effective in combination with echocardiography for patients with elevated levels.
However, in common with many accepted screening strategies, there are no randomised studies which show that screening the population with natriuretic peptides for asymptomatic LVF alters the natural history of the condition.
From a large, community based cardiovascular risk screening programme including more than 13,000 patients, patients in the catchment area of St Vincent's University Hospital are invited to participate in the STOP-HF study. The objective of this work is to determine whether or not using natriuretic peptide screening in conjunction with specialist follow-up will reduce the prevalence and severity of LVD in a well-defined, at-risk, primary care population. It also aims to: evaluate the natural history of natriuretic peptides over time in this population; to clarify optimal screening cut-offs for the detection of LVD; to evaluate the clinical, pharmacological, biochemical, genetic and proteomic determinants of natriuretic peptides in this setting; to determine whether the clinical benefits of the STOP HF screening programme, if any, are cost effective.
The study design is prospective, randomised and parallel group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •≥40 Years of age
- •with risk factors for LVD including:
- •hypertension (medicated for ≥ 1 month)
- •hypercholesterolemia
- •coronary artery disease (confirmed by angiography)
- •diabetes mellitus
- •arrhythmia
- •valvular abnormalities
排除标准
- •failure or unwilling to provide informed consent
- •known ventricular dysfunction (confirmed by angiography or echocardiography)
- •previous documented episode of heart failure
研究组 & 干预措施
Usual Care
Usual Care will involve ongoing management from the general practitioner, nurse-led assessment of cardiovascular risk at the general practice and referral to specialist services as deemed necessary.
Intervention
Intervention Care is defined as a collaborative cardiovascular management between primary care and specialist hospital based services. This will involve natriuretic peptide guided evaluation of LVD and follow-up as appropriate
干预措施: Intervention Care (Other)
结局指标
主要结局
Prevalence and severity of LVD
时间窗: 5 year
次要结局
未报告次要终点
研究者
Mark Ledwidge
Research Director, Heart Failure Unit St Vincent's University Hospital
St Vincent's University Hospital, Ireland