Evaluation of Lung Doppler Signals in Congestive Heart Failure(CHF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Diagnose specific pattern of LDS in patients by features as velocity, power etc in comparison to controls
研究概览
简要总结
The purpose of this study is to evaluate the lung Doppler signals in left HF patients with and without pulmonary congestion (i.e. decompensated left HF patients and compensated left HF patients respectively), in comparison to a control group of subjects without CHF (non-CHF controls), in order to determine the diagnostic value of this non-invasive method in CHF. If this method will prove to be of diagnostic value, it could potentially be used to diagnose and monitor CHF patients in both inpatient and outpatient settings.
详细描述
Study Participants A total of 150 patients will be recruited for this study over a span of 18 months.
Patients will be divided into 3 subgroups:
-
Acute decompensated left heart failure- Patients are eligible for enrollment if they presented to the emergency department within the previous few hours with acute pulmonary congestion or pulmonary edema, diagnosed on the basis of all of the following criteria:
-
Dyspnea at rest or with minimal activity
-
Rales on auscultation
-
Evidence of pulmonary congestion or edema on chest X-ray.
-
BNP level >400 pg/ml This subgroup will be recruited in the emergency medicine department (EMD) following initial treatment and stabilization.
-
Compensated left heart failure - Patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF and are without clinical or laboratory evidence of pulmonary congestion (i.e. patients without dyspnea at rest, without rales on auscultation and with BNP levels < 100 pg/ml). This subgroup will be recruited among inpatients and/or outpatients at the Rambam campus.
-
Non-CHF controls (patients without CHF and without uncontrolled hypertension). This subgroup will be recruited among inpatients and/or outpatients at the Rambam health care campus.
Study measurements
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •Age over 18 years
- •Belongs to one of the following categories:
- •A. Acute decompensated left HF: patients with acute pulmonary congestion or pulmonary edema diagnosed on the basis of all of the following criteria:
- •Dyspnea at rest or with minimal activity
- •Rales on auscultation
- •Evidence of pulmonary congestion or edema on chest X-ray.
- •BNP level >400 pg/ml
- •B. Compensated left HF: patients with significant stable left HF (NYHA II-III) who are on optimal medical treatment for CHF, and are without clinical or laboratory evidence of pulmonary congestion. The following 3 criteria must be met:
- •No dyspnea at rest
- •No rales on auscultation
- •BNP levels < 100 pg/ml
- •C. Non-CHF controls: patients without CHF and without uncontrolled hypertension.
- •3 Signed Informed Consent
排除标准
- •Decompensated left HF subgroup & Non CHF controls
- •Pneumonia- currently or in the past 1 month prior to inclusion
- •Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
- •Interstitial lung disease
- •Severe kyphosis, scoliosis or chest wall deformity
- •Pregnant women
- •Compensated left HF subgroup
- •Chronic obstructive pulmonary disease (COPD)
- •Interstitial lung disease
- •Any other obstructive or restrictive lung diseases
- •Pneumonia- currently or in the past 3 months prior to inclusion
- •Non-cardiogenic pulmonary edema or lung injury (e.g. ARDS)
- •Current or past pulmonary embolism
- •Large right sided pleural effusion
- •Severe kyphosis, scoliosis or chest wall deformity
- •Pregnant woman
结局指标
主要结局
Diagnose specific pattern of LDS in patients by features as velocity, power etc in comparison to controls
时间窗: 1.5y to collect all data and obtain a diagnostic pattern
次要结局
未报告次要终点