BioImpedentiometry and Lung UltraSound Examination to MOnitor cONgestion in Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Correlation between changes in total body water assessed by deuterium dilution (gold standard) and variations in body resistance by BioImpedentiometry
研究概览
简要总结
The purpose of this study is to validate non-invasive and user-friendly methods to monitor systemic and pulmonary congestion in heart failure patients.
The primary objective is to validate the role of bioimpedentiometry, pulmonary and subcutaneous ultrasound, to assess changes in total body water in patients with heart failure. vs the gold standard technique of deuterium oxide dilution Secondary objectives are
- to evaluate the applicability of bioimpedentiometry, pulmonary and subcutaneous ultrasound to monitor systemic, pulmonary and peripheral district congestion in relation with clinical and laboratory variables; 2)to analyze the organizational issues related to the use of these methods.
详细描述
Increased congestion leads to the clinical manifestation of heart failure (dyspnea, peripheral edema) and is considered the leading cause of hospital admissions and death among patients with HF Preclinical recognition of congestion in HF patients through home monitoring is crucial to prevent acute exacerbations and hospital admissions. Daily body weight, vital signs and fluid balance give only an indirect assessment of the level of congestion.
Deuterium oxide dilution is the non-invasive reference method for total body water assessment.
Bioelectrical impedance analysis (BIA) and chest ultrasound are simple, non-invasive techniques potentially applicable for home monitoring of congestion by non-physicians.
BIA is a noninvasive method for the study of body composition based on the measurement of body electrical resistance; BIA may allow measurement of whole body and segmental, e.g. pulmonary, fluids. However data on the value of BIA for the monitoring of HF patients are still scarce, inconclusive and relative to small cohorts of patients.
Lung ultrasound (LUS) through evaluation of B-lines, reverberation artifacts in the presence of extravascular lung water has been proposed as a semiquantitative tool to assess pulmonary congestion. B lines showed a good correlation with multiple indicators of congestion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Signed informed consent
- •Group-specific inclusion criteria:
- •Group 1 (Acute Heart Failure - AHF), patient admitted to the hospital for acute heart failure (de-novo or exacerbation of chronic heart failure), who have at least two of the following congestion criteria:
- •weight gain ≥ 2 kg over the three days prior to hospitalization
- •physical findings or radiographic signs of pulmonary congestion (crackles, semi-orthopnea)
- •Hepatomegaly > 2 cm from the arch rib or ascites
- •jugular turgor or central venous pressure > 10 cm H20
- •Ankle swelling
- •Group 2 (Chronic Heart Failure - CHF): outpatients with chronic heart failure (CHF) with characters of clinical stability
- •No hospitalization in the previous six months
- •Symptoms stable for at least 4 weeks
- •Oral therapy stable for at least 4 weeks
- •No involuntary weight variations greater than 2 kg in the last 4 weeks
- •Absence of signs of congestion
- •Group 3 (advanced Chronic Heart Failure - ad-CHF) Patients on optimal medical therapy for HF and treated with periodic infusions of levosimendan (every 4 weeks) according to the following criteria
- •Systolic dysfunction (LVEF <35%)
- •NYHA Class IIIb-IV and/or level INTERMACS 4, 5, 6
- •≥2 admissions or access to the emergency department for acute HF exacerbation in the previous 12 months
排除标准
- •Uremia in dialysis treatment
- •Invasive mechanical ventilation
- •Mechanical circulatory support
- •Cardiac cachexia defined as weight loss ≥ 5% in the prior 12 months or body mass index <20 kg/m2 and hypoalbuminemia (albumin <3.2 g/dl) or anemia (hemoglobin <12 g/l)
结局指标
主要结局
Correlation between changes in total body water assessed by deuterium dilution (gold standard) and variations in body resistance by BioImpedentiometry
时间窗: Group1 AHF Changes during hospital stay, with an expected average of 10 days; Group2 CHF Changes at 10±3 days from enrolment visit; Group3 ad-CHF Changes at 80±12h after levosimendan infusion from pre-infusion
次要结局
- execution time of BioImpedentiometry and Lung UltraSound Examination(Group 1 (AHF): hospital admission; Group 2 CHF: baseline outpatient visits; Group 3 (ad-CHF) baseline before levosimendan infusion)
- rates of patient refusal to undergo BioImpedentiometry and Lung UltraSound Examination(Group 1 (AHF): baseline at hospital admission; Group 2 CHF: baseline outpatient visit; Group 3 (ad-CHF) baseline before levosimendan infusion)
- Number of patients with B-lines documented by Lung Ultrasound who also show clinical evidence of pulmonary congestion, defined as presence of pulmonary rales or congestion by chest Xray, as a Measure of Diagnostic accuracy(Group 1 (AHF): hospital admission and hospital discharge)