NCT01936909已完成2 期
Interleukin-1 Blockade in Recently Decompensated Heart Failure: A Randomized Placebo-controlled Double-blinded Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Interval Changes in Peak Oxygen Consumption (VO2)
研究概览
简要总结
The RED-HART is a randomized double-blinded placebo-controlled study of Anakinra (IL-1 blocker) in patients with recently decompensated heart failure to determine the safety and efficacy in terms of aerobic exercise capacity and ventilatory efficiency measured with a cardiopulmonary exercise test.
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 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All 6 criteria need to be met for enrollment of the patient in the study
- •Primary diagnosis for hospitalization is decompensated heart failure established as the finding at admission of all 2 conditions listed below:
- •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);
- •pulmonary congestion/edema at physical exam OR chest X-Ray;
- •plasma Brain Natriuretic Peptide (BNP) levels ≥200 pg/ml;
- •invasive measurement of left ventricular end-diastolic pressure >18 mmHg or of pulmonary artery occluding pressure (wedge) >16 mmHg.
- •The patient has a prior documentation of impaired left ventricular systolic function (ejection fraction <50%) at most recent assessment by any imaging modality (within 12 months).
- •The patient is now clinically stable and meets standard criteria for hospital discharge as documented by all the 3 conditions listed below:
- •absence of dyspnea or pulmonary congestion/distress at rest;
- •absence of pitting edema in the lower extremities, or in any other region;
- •stable hemodynamic parameters (blood pressure, heart rate).
- •The patient is of age ≥21 years old, and is willing and able to provide written informed consent.
- •The patient is willing and able to comply with the protocol (i.e. self administration of the treatment, and exercise protocol).
- •The patient has screening plasma C-reactive protein levels >2 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)
Experimental
Anakinra 100 mg daily for 2 weeks, followed by placebo for 10 weeks
干预措施: Anakinra (weeks 1-2) (Drug)
Anakinra (long)
Experimental
Anakinra 100 mg daily for 12 weeks
干预措施: Anakinra (weeks 1-2) (Drug)
Anakinra (long)
Experimental
Anakinra 100 mg daily for 12 weeks
干预措施: Anakinra (weeks 3-12) (Drug)
Placebo
Placebo Comparator
Placebo injections daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Interval Changes in Peak Oxygen Consumption (VO2)
时间窗: Baseline to 2 weeks
Interval changes in peak oxygen consumption (VO2) after 2 weeks of anakinra treatment.
次要结局
- Quality of Life Improvement(12 weeks)
- Death or Hospital Admission for Heart Failure(24 weeks)
研究者
研究点 (1)
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