Pilot Study of the Safety and Efficacy of Anakinra (Recombinant Human Interleukin-1 Receptor Antagonist) in Pulmonary Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Median Interval Change From Baseline in Peak VO2
研究概览
简要总结
This is an open-label non-randomized, pilot study to evaluate the effect of Interleukin-1 blockade on exercise capacity in patients with pulmonary hypertension. Subjects will undergo cardiopulmonary exercise testing at baseline, and after 4 weeks treatment with Anakinra (recombinant human Interleukin-1 receptor antagonist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years
- •Diagnosis of PAH (from prior right heart catheterization), with functional class III symptoms of right ventricle failure despite optimal PAH therapy
- •Mean pulmonary artery pressure >25 mmHg
- •Pulmonary capillary wedge pressure <15 mmHg
- •Pulmonary vascular resistance >3 wood units
排除标准
- •PAH due to connective tissue disease (including scleroderma), interstitial lung disease (total lung capacity <65% predicted value), or cirrhosis (portopulmonary hypertension)
- •Angina or electrocardiograph (ECG) changes that limit maximum exertion during cardiopulmonary exercise testing or baseline ECG changes that limit the ability to detect ischemia (i.e. left bundle-branch block).
- •Recent (<14 days) use of anti-inflammatory drugs (not including NSAIDs), chronic inflammatory disorder (including but not limited to rheumatoid arthritis, systemic lupus erythematosus), malignancy, active infection, or any comorbidity limiting survival or ability to complete the study
- •Severe kidney dysfunction (eGFR <30 mL/min)
- •Thrombocytopenia (<50,000/mm3), or neutropenia (absolute neutrophil count <1,500/mm3)
- •Refusal by a woman of childbearing potential (not post-menopausal or surgically sterile) to use a medically acceptable form of birth control (including, but not limited to, a diaphragm, an intrauterine device (IUD), progesterone implants or injections, oral contraceptives, the double-barrier method, or a condom) throughout the duration of the study
- •History of hypersensitivity to anakinra or E. coli products
- •Latex or rubber allergy
- •Inability to give informed consent
研究组 & 干预措施
Anakinra
干预措施: Anakinra 100 mg subcutaneously daily (Drug)
结局指标
主要结局
Median Interval Change From Baseline in Peak VO2
时间窗: 28 days
Peak VO2 will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.
Median Interval Change From Baseline in the Minute Ventilation and Carbon Dioxide Production (VE/VCO2 Slope)
时间窗: 28 days
VE/VCO2 slope will be measured during a standardized cardiopulmonary exercise test in which patients exercise on a treadmill while breathing through a mask.
次要结局
- Interval Change From Baseline in Biomarkers (High-sensitivity C-reactive Protein, Whole Blood Assay, Brain Natriuretic Peptide)(28 days)
- Interval Change From Baseline in Heart Failure Symptoms as Measured by Duke Activity Status Index (DASI)(28 days)
- Correlation Between Interval Changes in Biomarkers, Peak VO2, and VE/VCO2(28 days)
- Rate of Adverse Events and Hospitalizations(28 days)
- Total Exercise Time(28 days)
- Oxygen Uptake Efficiency Slope(28 days)