NCT04877652已完成不适用
DR REGISTRY: Prospective Observational Study of Decongestion in Acute Heart Failure Patients With Insufficient Response to Diuretics
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- Serum Creatinine
研究概览
简要总结
The study objective is to observe and measure clinical outcomes, urine output, and safety events occurring during standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is >18 and < 85 years of age.
- •Subject is hospitalized with primary diagnosis of ADHF.
- •N-terminal-pro-brain natriuretic peptide (NT-proBNP) ≥1,600 pg/m or BNP≥400 pg/mL.
- •Evidence of fluid overload as indicated by 2 or more of the following criteria:
- •peripheral edema ≥ 2+
- •radiographic pulmonary edema or pleural effusion
- •enlarged liver or ascites
- •pulmonary rales or paroxysmal nocturnal dyspnea, or orthopnea
- •Jugular venous distention > 7 cmH2O
- •Subject insufficiently responds to IV diuretic therapy
排除标准
- •Systolic blood pressure <90 mmHg at the time of screening.
- •Acute myocardial infarction or acute coronary syndrome or cardiogenic shock or pleural synthesis within past 7 days or cardiovascular intervention within past 4 days.
- •Known LVEF < 15% by echocardiography within 1 year prior to enrolment.
- •Complex congenital heart disease (e.g., Tetralogy of Fallot subjects, single ventricle physiology).
- •Known active myocarditis, hypertrophic obstructive cardiomyopathy, constrictive pericarditis or cardiac tamponade.
- •Severe Aortic valvular disorder (i.e., hemodynamically relevant valvular diseases such as severe stenosis \severe regurgitation) or Severe mitral disease with planned intervention.
- •Evidence of active systemic infection documented by either one of the following: fever >38°C/100°F, or ongoing uncontrolled infection (i.e., inflammatory parameters not decreasing despite > 48 hours of antibiotic treatment).
- •Moribund subject or subject with severe or deteriorating damage in more than 3 critical body systems, based on investigator's clinical judgement.
结局指标
主要结局
Serum Creatinine
时间窗: Baseline [T=0] and 48 hours
Change in level
Serious Adverse Events
时间窗: 30 days
SAEs (including MACE) post enrollment based on CEC adjudication.
Urine Output
时间窗: Baseline [T=0-12h] and through 24 hours [T=12-36h]
Change in the rate
次要结局
未报告次要终点
研究者
研究点 (4)
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