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Interleukin (IL)-1 Blockade in Acute Heart Failure (Anakinra ADHF)

2016年3月31日 更新者:Virginia Commonwealth University

Interleukin-1 Blockade in Acute Decompensated Heart Failure

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.

研究概览

研究类型

介入性

注册 (实际的)

30

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Virginia
      • Richmond、Virginia、美国、23298
        • Virginia Commonwealth University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

21年 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

All 5 criteria need to be met for enrollment of the patient in the study

  1. Primary diagnosis of acute decompensated heart failure within the last 24 hours as evidenced by both of the following:

    1. dyspnea or respiratory distress or tachypnea at rest or with minimal exertion
    2. 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.

  2. Left ventricular systolic dysfunction (LVEF<40%) during index hospitalization or prior 12 months.
  3. Age ≥18 years old
  4. Willing and able to provide written informed consent.
  5. 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.

  1. The primary diagnosis for admission is NOT decompensated heart failure, including diagnosis of acute coronary syndromes, hypertensive urgency/emergency, tachy- or brady-arrhythmias.
  2. 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.
  3. Recent (previous 3 months) or planned cardiac resynchronization therapy (CRT), coronary artery revascularization procedures, or heart valve surgeries.
  4. Previous or planned implantation of left ventricular assist devices or heart-transplant.
  5. Chronic use of intravenous inotropes.
  6. Recent (<14 days) use of immunosuppressive or anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]).
  7. Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus).
  8. Active infection (of any type);
  9. Chronic/recurrent infectious disease (including Hepatitis B virus [HBV], Hepatitis C virus [HCV], and HIV/AIDS).
  10. Prior (within the past 10 years) or current malignancy.
  11. Any comorbidity limiting survival or ability to complete the study.
  12. End stage kidney disease requiring renal replacement therapy.
  13. Neutropenia (<2,000/mm3) or Thrombocytopenia (<50,000/mm3).
  14. Pregnancy.
  15. Angina, arrhythmias, or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing obtained during the baseline testing.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:Anakinra (short)
Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14
Anakinra 100 mg daily twice daily for days 1, 2, and 3
Anakinra 100 mg daily for days 4-14
安慰剂比较:Placebo
Placebo injections twice daily for the first 3 days then once daily for days 4-14.
Placebo twice daily for days 1, 2, and 3
Placebo daily for days 4-14

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
C Reactive Protein
大体时间: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"
3 days

次要结果测量

结果测量
措施说明
大体时间
Left Ventricular Ejection Fraction
大体时间:14 days
Change in left ventricular ejection fraction (LVEF) between admission and 14 day follow up. This value is expressed as absolute change in measured LVEF. For example, if baseline LVEF = 20% and 14 day LVEF = 25%, this would be reported as an absolute change of 5%.
14 days
Brachial Artery Vasoreactivity
大体时间:14 days
Change in flow mediated vasodilatation (FMD) of the brachial artery. Brachial artery FMD is calculated as the percentage increase in brachial artery diameter with hyperemia (an increase in the quantity of blood flow to a body part) induced relative to the resting brachial artery diameter. Percentage of brachial artery diameter is measured as FMD diameter/basal diameter. The change is FMD is reported as the % change in FMD from baseline to 14 days.
14 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Benjamin W Van Tassell, PharmD、Virginia Commonwealth University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年2月1日

初级完成 (实际的)

2015年5月1日

研究完成 (实际的)

2015年5月1日

研究注册日期

首次提交

2013年9月3日

首先提交符合 QC 标准的

2013年9月3日

首次发布 (估计)

2013年9月6日

研究记录更新

最后更新发布 (估计)

2016年5月5日

上次提交的符合 QC 标准的更新

2016年3月31日

最后验证

2016年3月1日

更多信息

与本研究相关的术语

其他研究编号

  • VCU HM15347

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Data may be available upon request

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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