NL-OMON31659已完成3 期
Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure - ASCEND-HF
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- Men or women 18 years of age or older
- •- Hospitalized for the management of ADHF or diagnosed with ADHF within 48 hours after being hospitalized for another reason
- •- Diagnosis of ADHF must meet the following definition:
- •- Dyspnea at rest or dyspnea with minimal activity
- •AND at least 1 of the following signs:
- •- Tachypnea with respiratory rate >20 breaths per minute, OR
- •- Pulmonary congestion/edema with rales or crackles/crepitations at least one-third above lung base
- •AND at least 1 of the following objective measures:
- •- Chest x-ray with pulmonary congestion/edema, OR
- •- B-type natriuretic peptide ³400 pg/mL or NT-proBNP ³1,000 pg/mL at presentation, OR
- •- Pulmonary capillary wedge pressure >20 mmHg, OR
- •- Ejection fraction <40% measured by any modality (echocardiography, nuclear testing, cardiac MRI, ventricular angiography) within 12 months before randomization without intervening revascularization or cardiac surgery
排除标准
- •- Hospitalized for more than 48 hours before randomization
- •- Likely to be discharged from the hospital in 24 hours or less
- •- At high risk for hypotension:
- •- Baseline SBP <100 mmHg or
- •- Systolic blood pressure <110 mmHg with i.v. nitroglycerin or another i.v. vasodilator used at baseline
- •- Persistent, uncontrolled hypertension (SBP >180 mmHg)
- •- Have any of the following cardiovascular disease parameters:
- •- Echocardiogram (ECG) with new ST elevation >1 mm in 2 consecutive leads
- •- Acute coronary syndrome as primary diagnosis
- •- A coronary catheterization or other coronary intervention is planned within 48 hours
- •- History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic obstructive cardiomyopathy, or pericardial tamponade
- •- PCWP =<20 mmHg within 6 hours before randomization (only if measured)
- •- Have a left ventricular assist device
- •- Medication History:
- •- Received first i.v. treatment of diuretics, vasodilators or inotropes for HF more than 24 hours before randomization
- •- Treated with levosimendan or milrinone within 30 days before randomization or anticipated need for one of these medications during the current hospitalization
- •- Treated with i.v. nitroglycerin, i.v. dobutamine <5 mg/kg/min or another i.v. vasoactive medication, the dosage of which is not stable for 3 hours before randomization
- •- Treated with dobutamine >= 5 mg/kg/min. at the time of randomization
- •- Had prior therapy with nesiritide in the past 30 days, or anticipate the need for open-label nesiritide during the current hospitalization
- •- Known allergic reaction or hypersensitivity to nesiritide
- •- Laboratory abnormalities (when laboratory values are available)
- •- Troponin level >5 times the upper limit of normal (ULN)
- •- Creatine kinase - MB (CK-MB) levels >3 times ULN
- •- BNP or NT-proBNP is within normal limits (i.e., BNP <100 pg/mL or NT-proBNP <125 pg/mL for subjects <75 years old; NT proBNP <425 pg/mL for subjects >=75 years old)
- •Comorbid Diseases
- •- Chronic or intermittent renal support therapy (hemodialysis, ultrafiltration, or peritoneal dialysis)
- •- Significant chronic or acute lung disease that might interfere with the ability to interpret the dyspnea assessments
- •- Serious comorbid disease in which the life expectancy of the subject is less than 6 months
- •- Active gastrointestinal bleeding
研究者
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