a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- To study the prevalence of distinct congestion phenotypes
研究概览
简要总结
The goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. The main question[s] it aims to answer [is/are]:
-
Primary objective: to study the prevalence of distinct congestion phenotypes
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Other objectives (including):
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Response to therapy as assessed by
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Natriuresis after 24 hours
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Rehospitalization and/or deats after 6 months
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Length of hospital stay
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Congestion at discharge
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Changes in filling pressures over time
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Relationship between liver stiffness, as assessed with Fibroscan and congestion
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Substudy: glycosaminoglycan netword and endothial glycocalyx
Participants will undergo several extra study related measurements:
- Assessment of filling pressures with ultrasound
- Ultrasound investigation of the lungs and kidneys
- Fibroscan of the liver
- Sidestream darkfield imaging sublingual
- As part of substudy GLYCO-AHF: skin biopsy to determine glycocalyx, as well as salt and water content.
- As part of substudy PREACH-AHF: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins
详细描述
Objective: to study the prevalence of distinct congestion phenotypes and investigate their association with response to therapy and outcomes in acute heart failure patients.
Study design: Observational, prospective study
Study population: 270 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.
Main study parameters/endpoints:
To identify distinct congestion phenotypes and study their association with response to therapy and outcomes
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give written informed consent
- •Age ≥ 18 years
- •Male or female
- •Primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion. Diagnosis is based on the criteria in the ESC HF guidelines (1)
- •Requirement of intravenous loop diuretics
排除标准
- •Patients with severe kidney dysfunction (in need for ultrafiltration or dialysis)
- •Previous participation in this study
- •Inability to follow instructions
- •Dyspnoea or oedema primarily due to non-cardiac causes
结局指标
主要结局
To study the prevalence of distinct congestion phenotypes
时间窗: From date of hospital admission untill the date of discharge (from this admission), with an expected discharge after 5 to 10 days after admission.
Based on the degree of congestion and edema in combination with intravascular pressures, patients will be classified into different phenotypes (high/low intravascular pressures and extensive/minimal edema.
次要结局
- Total natriuresis after 24 hours(24 hours)
- Rehospitalization and/or death after 6 months(180 days)
研究者
Jozine ter Maaten
Principal Investigator
University Medical Center Groningen