Uppsala Self-SCREENing of Heart Failure Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Detection of undiagnosed heart failure (HF) in high-risk patients.
研究概览
简要总结
The goal of this clinical trial is to investigate whether a stepwise multimodal home-based screening strategy with rapid point-of-care testing can detect undiagnosed heart failure (HF) in high-risk patients compared to usual care. The study also aims to understand the impact of earlier HF diagnosis on treatment initiation, clinical outcomes, symptoms, functional capacity, health-related quality of life, healthcare utilization, and costs.
The main questions it aims to answer are:
Does a home-based screening strategy increase the diagnosis of HF within 6 months compared to usual care?
Does earlier diagnosis lead to more patients receiving guideline-directed medical therapy (GDMT) for HF with reduced ejection fraction (HFrEF) within 6 months?
What is the impact of this screening strategy on HF hospitalizations, mortality, functional capacity, health-related quality of life, and healthcare costs over 1, 2, and 5 years?
Researchers will compare a stepwise multimodal home-based screening strategy to usual care to determine if the screening strategy leads to earlier HF diagnosis and improved patient outcomes.
Participants will:
Provide dried blood spot samples for NTproBNP analysis by mail.
If NTproBNP is elevated (≥125 pg/ml), undergo point-of-care NTproBNP testing and an AI-enabled echocardiogram.
Be followed for up to 5 years through healthcare databases and self-reported symptom monitoring to track HF diagnosis, treatment initiation, clinical outcomes, and healthcare utilization.
The study will randomize 500 high-risk participants in a 1:1 ratio to either the ACTIVE arm (home-based screening) or the CONTROL arm (usual care). Participants with known HF are excluded.
The primary outcome is the diagnosis of HF within 6 months. Secondary outcomes include the diagnosis of HFrEF and initiation of GDMT within 6 months. Exploratory outcomes will assess long-term clinical outcomes (HF hospitalizations and death), functional capacity, quality of life, and cost-effectiveness at 1, 2, and 5 years.
This investigator-initiated trial is part of the international SYMPHONY study and is coordinated from Uppsala University and Uppsala University Hospital, Sweden. The study will use healthcare databases, registries, and digital resources for comprehensive outcome capture. The first patient visit is scheduled for February 1, 2023, with follow-up extending to August 2026 for the primary outcome and up to 5 years for exploratory outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥40 years, and at least one of the following symptoms of HF, and at least two risk factors for HF:
- •Dyspnoea on exertion
- •Dyspnoea at rest
- •Orthopnoea
- •Paroxysmal nocturnal dyspnoea
- •Reduced exercise tolerance, increased time to recover after exercise
- •Fatigue, tiredness
- •Ankle swelling
- •Risk factors
- •Diabetes (type 1 or type 2)
- •Coronary artery disease (myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention)
- •Persistent or permanent atrial fibrillation (not paroxysmal atrial fibrillation)
- •Previous ischemic or embolic stroke
- •Peripheral arterial disease (previous surgical or percutaneous revascularisation)
- •Chronic kidney disease
- •Regular loop diuretic use (any dose at any dosing interval) for >30 days
- •COPD (diagnosis by respiratory physician, radiological emphysema or treatment with advocated COPD therapy)
排除标准
- •Previous diagnosis of HF
- •Previous renal replacement therapy
- •Inability to comply with study procedures or provide informed consent
结局指标
主要结局
Detection of undiagnosed heart failure (HF) in high-risk patients.
时间窗: Within 6 months.
Diagnosis of HF; HF is defined as either: 1. an outpatient diagnosis of heart failure according to the ESC 2021 Heart Failure Guidelines, 2. outpatient heart failure visit, 3. an urgent heart failure visit, or 4. a heart failure hospitalisation.
次要结局
未报告次要终点