Ultrasound Evaluation of the Inferior Vena Cava in Addition to Clinical Assessment to Guide Decongestion in Acute Decompensated Heart Failure: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 388
- 试验地点
- 2
- 主要终点
- Change in NT-proBNP from baseline to discharge
研究概览
简要总结
CAVA-ADHF is designed as a prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial. The objective is to test whether evaluation of the inferior vena cava diameter in addition to clinical assessment is superior compared to clinical assessment alone with respect to the surrogate endpoint of change in NT-proBNP from baseline to discharge. The CAVA-ADHF trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).
详细描述
Only limited evidence is available on the best method to monitor and guide decongestion in acute decompensated heart failure. Therefore, no specific guideline recommendations are made in this regard. It is unknown whether an objective congestion marker can be used to guide decongestion or such marker is only of prognostic value by identifying high-risk patients with an advanced disease state.
CAVA-ADHF is designed as prospective, randomized, controlled, patient-blinded, multicenter, parallel-group trial and aims to demonstrate effectiveness of inferior vena cava (IVC)-guided decongestion, its feasibility, and to estimate effect size and variability of clinical endpoints following the intention-to-treat principle.
After inclusion and exclusion criteria have been checked patients will be randomized:
Experimental intervention: Decongesting treatment guided by clinical assessment and ultrasound evaluation of the IVC diameter. Decongestion should lead to a maximal IVC diameter ≤2.1 cm and IVC collapsibility index >50% in addition to relief of symptoms and signs of congestion before discharge.
Control intervention: Decongesting treatment guided by clinical assessment alone. The IVC ultrasound evaluation is performed, but results are not reported to treating physicians.
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
- Double (Participant, Care Provider)
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
- •Hospitalization for ADHF with dyspnea ≥NYHA III, peripheral edema, and pulmonary congestion (rales on auscultation or pulmonary vascular congestion on chest radiograph)
- •Age ≥18 years
- •NT-proBNP >300 ng/l within 24 h after admission
- •Sufficient ultrasound visualization to evaluate IVC
- •IVCmax >2.1 cm and IVCCI ≤50 % in the baseline assessment within 24 h after admission
- •Capability to sign informed consent personally
排除标准
- •Cardiogenic shock with systolic blood pressure <90 mmHg plus end-organ hypoperfusion
- •ADHF due to significant arrhythmias
- •Severe pulmonary disease as primary cause of dyspnea
- •Simplified Modification of Diet in Renal Disease estimated glomerular filtration rate <30 ml/min/1.73 m²
- •Need for non-invasive or invasive ventilation support at baseline
- •Pregnancy
- •Participation in another interventional trial regarding heart failure treatment
研究组 & 干预措施
Clinical assessment only
Decongesting treatment guided by clinical assessment alone
干预措施: Sham ultrasound evaluation of the inferior vena cava diameter (Diagnostic Test)
Clinical assessment plus IVC diameter
Decongesting treatment guided by clinical assessment and ultrasound evaluation of the inferior vena cava diameter
干预措施: Ultrasound evaluation of the inferior vena cava diameter (Diagnostic Test)
结局指标
主要结局
Change in NT-proBNP from baseline to discharge
时间窗: Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission)
The core laboratory at Luebeck will determine NT-proBNP levels for calculation of the endpoint from samples obtained at baseline and at discharge.
次要结局
- Proportion of patients with IVC ultrasound on two thirds of days in hospital and at discharge among all randomized patients(Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission))
- Readmission for heart failure(180 days after randomization)
- All-cause mortality(180 days after randomization)
- Cardiovascular mortality(180 days after randomization)
- Unscheduled readmission for any cause(180 days after randomization)
- Cumulative loop diuretic dose during index hospitalization(Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission))
- Length of index hospitalization(Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission))
- Hemoconcentration(Measured at baseline (within 24 hours of admission to index hospitalization) and on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission))
- Freedom from signs of congestion at discharge(Measured on the day of discharge from index hospitalization (discharge planning is at the discretion of treating physician but will be around 5 to 8 days after admission))
研究者
Holger Thiele
Director
University of Luebeck