NCT01542502已完成不适用
Pilot Feasibility Study of the Safety and Efficacy of Anakinra in Heart Failure With Preserved Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Peak Oxygen Consumption (Peak VO2)
研究概览
简要总结
This will be a randomized, double-blind, crossover pilot study to measure the safety and feasibility of Interleukin-1 (IL-1) blockade with Anakinra in patients with stable heart failure with preserved ejection fraction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptoms and signs of congestive heart failure
- •Recent Imaging Study (<12 months) showing Left Ventricular Ejection Fraction (LVEF) >50% and Left Ventricular End Diastolic Volume Index (LVEDVI) <97ml/m2
- •Evidence of abnormal Left Ventricular (LV) relaxation, filling, diastolic distensibility, and diastolic stiffness as shown by one of the following:
- •Invasive Hemodynamic measurements
- •mean Pulmonary Capillary Wedge pressure (mPCW) >12
- •Left Ventricular End Diastolic Pressure (LVEDP) >16 mmHg
- •Tissue Doppler Echocardiogram
- •E/E' >15
- •E/E' 8-15 and one of the following
- •Left Ventricular Hypertrophy (LVH)
- •Atrial Fibrillation
- •Left Atrial Enlargement
- •E/A <0.5 + Deceleration Time (DT) >280 (if >50yrs of age)
- •Brain Natriuretic Peptide (BNP) >200pg/mL
排除标准
- •Recent changes (previous 3 months) in HF maintenance medications (beta-blockers, angiotensin converting enzyme [ACE] inhibitors, aldosterone antagonists, vasodilators, cardiac glycosides, diuretics)
- •Hospitalization for worsening Heart Failure (HF) or acute decompensated HF within the previous 12months
- •Anticipated need for cardiac resynchronization therapy (CRT) or automated-implantable cardioverter defibrillator (AICD)
- •Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing
- •Active infection including chronic infection
- •Active cancer
- •Recent (<14 days) use of anti-inflammatory drugs (not including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]), Chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, or any comorbidity limiting survival or ability to complete the study
- •Pregnancy (determined by urine pregnancy test in women of childbearing potential)
- •Inability to give informed consent
- •Other conditions limiting completion of cardiopulmonary exercise test or completion of the study
研究组 & 干预措施
Anakinra
Experimental
Treatment with daily subcutaneous injections of Anakinra 100 mg
干预措施: Anakinra (Drug)
Placebo
Placebo Comparator
Treatment with daily subcutaneous injection of placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Peak Oxygen Consumption (Peak VO2)
时间窗: 14 days
The primary endpoint is the change in peak oxygen consumption among stable heart failure patients (n = 12) following 14-days treatment with daily doses of Anakinra 100 mg (SC, subcutaneous).
次要结局
- Exercise Time(14 days)
研究者
研究点 (1)
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