Interleukin-1 Blockade in Acute Decompensated Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- C Reactive Protein
研究概览
简要总结
Anakinra ADHF is a double-blind randomized clinical trial of anakinra, recombinant human interleukin-1 receptor blocker, or placebo in patients with acute decompensated heart failure with the aim to quench the acute inflammatory response, as measured by the area-under-the-curve for C reactive protein over 14 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All 5 criteria need to be met for enrollment of the patient in the study
- •Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:
- •dyspnea or respiratory distress or tachypnea at rest or with minimal exertion
- •evidence of elevated cardiac filling pressure or pulmonary congestion (at least one of the conditions must be met);
- •i. pulmonary congestion/edema at physical exam OR chest x-ray; ii. plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/mL; iii.invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
- •Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months.
- •Age ≥18 years old
- •Willing and able to provide written informed consent.
- •Screening plasma C-reactive protein levels >5 mg/L.
- •Exclusion Criteria Subjects will not be eligible if they meet any of the following 15 exclusion criteria.
- •The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
- •Concomitant clinically significant comorbidities that would interfere with the execution or interpretation of the study including but not limited to acute coronary syndromes, uncontrolled hypertension or orthostatic hypotension, tachy- or brady-arrhythmias, acute or chronic pulmonary disease or neuromuscular disorders affecting respiration.
- •Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
- •Previous or planned implantation of left ventricular assist devices or heart-transplant.
- •Chronic use of intravenous inotropes.
- •Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
- •Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
- •Active infection (of any type);
- •Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).
- •Prior (within the past 10 years) or current malignancy.
- •Any comorbidity limiting survival or ability to complete the study.
- •End stage kidney disease requiring renal replacement therapy.
- •Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
- •Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.
排除标准
- 未提供
研究组 & 干预措施
Anakinra (short)
Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
干预措施: Anakinra (high dose) (Drug)
Anakinra (short)
Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
干预措施: Anakinra (standard dose) (Drug)
Placebo
Placebo injections twice daily for the first 3 days then once daily for days 4-14.
干预措施: Placebo (Drug)
结局指标
主要结局
C Reactive Protein
时间窗: 3 days
The proportional area-under-the-curve for plasma C reactive protein (CRP) levels measured during the first 3 days of admission. The proportion (y-axis) is calculated at each time-point with respect to the baseline CRP. The resultant y-axis is a unitless proportion. The x-axis is listed as "days"
次要结局
- Left Ventricular Ejection Fraction(14 days)
- Brachial Artery Vasoreactivity(14 days)