Phase II Clinical Trial Testing the Safety of a Humanized Monoclonal Antibody Anti-CD20 in Patients With Heart Failure With Reduced Ejection Fraction
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 主要终点
- Incidence of Rituximab Emergent Cardiovascular Adverse Events
研究概览
简要总结
The study is a phase II single-centered, single group, prospective clinical trial to evaluate the safety of HMA-CD20 doses among stable patients with class III/IV according to the NYHA classification with HFrEF receiving standard of care therapy. The index qualifying HFrEF must have EF < 40% based on echocardiographic or cardiac MRI techniques, heart failure class III/IV according to the NYHA classification,aged 40-60 years, being diagnosed less than 12 months before enrollment of study, following the standard heart failure treatment regimen.
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
- 40 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Interventional Group
For this trial, HMA-CD20 will be given as an intravenous infusion of 1000 mg I.V twice in a month separating them by fourteen days starting at the baseline visit. The dose for both HMA-CD20 dosages willbe identical at the screening visit after the participant's eligibility has been established, and it will remain thesame for both infusions. The standard dose for HMA-CD20 is 1,000 mg per intravenous infusion on day 1 and day 15.
干预措施: Rituximab (Drug)
结局指标
主要结局
Incidence of Rituximab Emergent Cardiovascular Adverse Events
时间窗: 6 months
The investigators analyze the safety of rituximab based on the occurrence of cardiovascular adverse events such as arrhythmia, worsening of symptoms and acute coronary syndromes.
次要结局
未报告次要终点
研究者
David Rodriguez
MD
Instituto de Cardiología y Medicina Vascular Hospital Zambrano-Hellion Tec Salud