NCT06003972已完成2 期
Asses the Anti-inflammatory Effects of Short Term Copaxone Therapy on Patients the Acute Decompensated Heart Failure
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
- 14
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
Assess the anti-inflammatory effects of short-term Copaxone therapy on patients with acute decompensated heart failure.
Trial Design
- An open-label, randomized, prospective trial of patients hospitalized due to acute decompensation of heart failure with reduced ejection fraction.
- Patients will be enrolled within 24 hours from hospital admission.
- Randomization and intervention will begin within 24 hours of enrollment (and at least 24 hours after admission).
- Patients will be randomized in a 1:1 ratio either to receive guideline directed medical therapy (GDMT) or GDMT plus Copaxone.
- Patients assigned to intervention group will receive daily SC Copaxone 20 mg for 14 days.
- Patients will be assessed during 4 time points(screening/randomization, visit 3 day, visit 14 day, visit 30 day) as elaborated in article "monitoring".
- Changes in inflammatory cytokines will be compared between control and intervention group throughout 3 time points.
- The trial will be approved by the institutional view board and conducted in accordance with the principles or Good Clinical Practice guidelines and the Declaration of Helsinki.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •STAGE CHF BASELINE NYHA functional class II-III and established diagnosis of ischemic cardiomyopathy
- •Hospitalization due to acute decompensated CHF
- •GDMT for at least 3 months prior to enrollment
排除标准
- •Current hospitalization:
- •Hemodynamic instability necessitating inotropic or mechanical circulatory support
- •Respiratory failure necessitating invasive mechanical ventilation
- •Active infection
- •A different etiology to explain SIRS other than CHF exacerbation.
- •Prior hospitalizations or need of intravenous diuretic therapy in the last 30 days before current hospitalization
- •Cardiac co-morbidities:
- •Specific HF etiologies:
- •Pericardial disease
- •Infiltrative myocardial disease
- •Moderate and above Valvular heart disease Acute coronary syndrome in the preceding 60 days to randomization Evidence of significant cardiac ischemia within 1 year of randomization without revascularization since Stroke or TIA in the preceding 30 days from randomization
- •Complex congenital cardiac defect
- •New initiation of cardiac resynchronization therapy within 60 days prior to randomization
- •Life threatening arrhythmias /ICD ACTIVATION- in last 90 days Listing for heart transplantation or anticipated/implanted ventricular assist device
- •Non-cardiac co-morbidities:
- •Glomerular filtration rate <30 mL/min/1.73m2 calculated by MDRD formula
- •Hepatic insufficiency classified as Child-Pugh B or C
- •SBP >180 mm Hg or <110 mm Hg NOT RESPONSIVE TO THERAPY
- •Morbid obesity with a BMI >40 kg/m2
- •Severe pulmonary disease with requirement of home oxygen therapy or important nocturnal desaturation
- •Active treatment for malignancy in the past 2 years or neoplastic spread beyond organ of origin (lymphatic metastases included)
- •Hemoglobin <8 g/dL
- •Known previous systemic inflammatory disease
- •Alcohol or drug abuse Chronic treatment with Copaxone, cytotoxic, immunosuppressant or biological treatment in the past two years.
- •Known Pregnancy Incapability of signing IC due to cognitive or mental reason Poor compliance to medical therapy or inability to complete the study Age >80 years
研究组 & 干预措施
Control
Active Comparator
This arm serves as the control arm, patients allocated receive guideline directed medical therapy only
干预措施: guideline directed medical therapy (GDMT) (Drug)
Copaxone arm
Experimental
Patients receive guideline directed medical therapy with an add-on GA therapy for 14 days
干预措施: Copaxone (Drug)
结局指标
主要结局
Primary Endpoint
时间窗: 3 weeks
%change in inflammatory cytokines from baseline to Day 3 and 2 weeks (up to 3 weeks), compared between intervention vs. control groups
次要结局
未报告次要终点
研究者
RABEA ASLEH
Professor
Hadassah Medical Organization
研究点 (1)
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