Peripheral Drivers of Heart Failure Progression - The Prospective PEDAL-HF Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Change in NT-proBNP plasma levels between baseline and 6 months visit
研究概览
简要总结
PEDAL-HF is a registry-based randomized prospective multicenter study. The investigators plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up.
All patients (randomized or not) will be followed for two years.
详细描述
See above.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The primary endpoint (NT-proBNP) will be measured by lab personnel blinded to patients´ group assignment
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
- •Patients admitted to the participating study centres with acute decompensated heart failure (ADHF), defined as clinical signs and/or symptoms of heart failure
- •objective structural cardiac abnormalitites according to the ESC criteria.
排除标准
- •Age <18 years
- •pregnancy
- •any condition interfering with the informed consent process
- •patients placed in an institution by official or court order
研究组 & 干预措施
Registry Arm for non-randomised patients
Patients not willing to be randomised will be followed in a registry.
Randomised Arm 1: Heart Failure Network Care
Patients will receive three follow-up visits during the vulnerable period (three month after hospital discharge) in the HF network (either cardiologist in private practice or HF outpatient clinic)
干预措施: Heart Failure network care (Other)
Randomised Arm 2: Usual care
Patients will receive usual care by their primary physician or cardiologist
结局指标
主要结局
Change in NT-proBNP plasma levels between baseline and 6 months visit
时间窗: 6 months
Adjusted geometric mean ratio between 6 months visit and baseline visit
次要结局
- Change in KCCQ from baseline to 6 months of Follow-up(6 months)