NCT04549701已完成不适用
Inferior Vena CAVA and Lung UltraSound-guided Therapy in Acute Heart Failure: a Randomized Controlled Pilot Trial (CAVAL US-AHF Study)
Instituto Cardiovascular de Buenos Aires2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Subclinical congestion at discharge
研究概览
简要总结
Between 25% and 30% of patients hospitalized for acute heart failure (AHF) are readmitted within 90 days after discharge. Mostly due to persistent congestion on discharge. However, as the optimal evaluation of decongestion is not clearly defined, it is necessary to implement new tools to identify subclinical congestion to guide treatment.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
CAVAL US will be performed on all patients, and patients will be blinded to the assigned group.
The treating medical team will be blind to the CAVAL US results of the control group.
Independent clinicians adjudicating 90-day events will not participate in patient follow-up, and will be blind to the assigned group.
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 of 24 hours or greater for decompensated heart failure defined as new-onset of symptoms or worsening of previous symptoms (including orthopnea, progression to FC III-IV, bendopnea or fatigue) or signs of volume overload.
- •and - Jugular venous distension, hepatojugular reflux, lower extremity edema or signs of pulmonary congestion.
- •Chest X-ray with signs suggestive of pulmonary congestion. and
- •Elevated ´pro-B-type natriuretic peptide (NT-proBNP) levels of 450 pg/mL, 900 pg/mL, and 1800 pg/mL for ages < 50 years, 50 to 75 years, and > 75 years, respectively, within 24 hours of admission (53,54).
- •- Sufficient ultrasound visualization to assess IVC and lungs.
排除标准
- •Not willing to participate.
- •Life expectancy of less than 6 months.
- •Uninterpretable lung or inferior vena cava ultrasound.
- •Transfer to another hospital before hospital discharge.
- •SBP < 90 mm Hg.
- •Chronic kidney disease (creatinine clearance <30 mL/min calculated with the MDRD equation or hemodialysis).
- •Requirement for invasive or noninvasive ventilator support.
- •Pregnancy.
- •Low cardiac output syndrome/cardiogenic shock.
- •Death during index hospitalization.
- •Acute coronary syndrome, myocardial revascularization or heart valve replacement within the previous 3 months.
- •Being on heart transplant waiting list.
- •Cardiac resynchronization therapy device implanted within the previous 3 months.
- •Severe tricuspid valve regurgitation.
- •Heart failure secondary to causes amenable to invasive correction: cardiac surgery, percutaneous interventions or pacemaker implantation.
- •Heart failure secondary to significant arrhythmias (advanced atrioventricular block or sinus arrest, sustained ventricular tachycardia or any sustained arrhythmia other than atrial fibrillation causing hemodynamic instability according to the discretion of the treating physician).
- •Heart failure secondary to severe systemic infection
- •Severe psychiatric illness
- •Palliative care
- •SARS-CoV-2 infection
结局指标
主要结局
Subclinical congestion at discharge
时间窗: Discharge
次要结局
- Readmission for heart failure, unplanned visit for worsening HF, or death.(90 days)
研究者
Lucrecia Maria Burgos
Principal investigator
Instituto Cardiovascular de Buenos Aires
研究点 (2)
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