A Parallel-group, Single-center, Two-arm Treatment Study to Assess the Safety and Effectiveness of Venous Ultrasound Guided Decongestion in Adult Patients Hospitalized with Acute Decompensated Heart Failure.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Change in VExUS score
研究概览
简要总结
The purpose of this study is to assess the feasibility, safety and effectiveness of VExUS guided organ decongestion compared to standard of care in patients hospitalized with acute decompensated heart failue (ADHF).
180 patients will be randomly assigned to either intervention (VExUS) arm or standard of care (SOC) arm. In the intervention arm, the treatment team will be informed by the study team about the results of the VExUS examination to supplement the clinical decision of proper decongestion treatment, while no information will be provided in the standard of care arm. Study visits are scheduled every second day while hospitalized, end of study is set to day of discharge from the ward. Telephone consultation and review of medical journal scheduled after 6 months to assess exploratory endpoints.
The overall rationale of the the study is to investigate if venous organ congestion investigated by VExUS score, is a modifiable risk factor in patients hospitalized with ADHF. And secondary to assess if venous organ decongestion guided by VExUS score may safely be implemented in patients hospitalized with ADHF and result in:
- differences in length of hospitalization
- changes in biomarkers of cardiac strain
- changes in renal function and markers of renal injury
- achieved doses of heart failure treatment at discharge
- in-hospital complications
Safety measures with special attention on symptomatic hypotension, arrhythmias, metabolic alkalosis and electrolyte disturbances will be addressed.
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
- •18 years of age or above
- •Admitted the ward of Department of Cardiology OUH Ullevål with a clinical diagnosis of ADHFdefined by European Society of Cardiology
- •Pro-BNP > 800 ng/l at first day of admission
- •Capable of giving signed informed consent
排除标准
- •Any medical or psychiatric condition which in the opinion of the investigatorprecludes participation
结局指标
主要结局
Change in VExUS score
时间窗: From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.
The findings from Doppler ultrasonography of the hepatic vein, portal vein, and interlobar renal vein will be graded using the VExUS score, which reflects the degree of venous congestion. The scale ranges from 0 to 3, where a score of 0 indicates no signs of congestion, 1 indicates mild congestion, 2 indicates moderate congestion, and 3 indicates severe congestion.
次要结局
- Change in NT-ProBNP(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
- Change in estimated renal glomerular filtration rate(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
- Change in urine albumin creatinine ratio(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
- Change in symptoms(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
- Length of hospitalization(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
- Achieved dosage of HF medications at discharge(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
- Safety(From the time of enrollment until hospital discharge, typically ranging from 3 to 21 days.)
研究者
Bård Waldum-Grevbo
Medical professor, MD, PhD
Oslo University Hospital