NCT06922851招募中不适用
Protein A Immunoadsorption in Dilated Cardiomyopathy: A Prospective, Multicenter, Randomized Study to Evaluate Efficacy and Safety (PRIA-DCM)
Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年6月4日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in LVEF from baseline to 6 months determined by echocardiography
研究概览
简要总结
This study is a multicenter, dual-arm and randomized controlled clinical trial. Sixty patients with dilated cardiomyopathy and positive β1-adrenergic receptor autoantibodies were selected and randomly divided into an immunoadsorption group (receiving immunoadsorption therapy) and a control group in a 1:1 ratio. Changes in cardiac function, morphology and clinical outcomes were followed up and compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dilated cardiomyopathy
- •Presence of anti-β1-adrenergic receptor
- •Age 18-75 years
- •LVEF ≤ 40% determined by echocardiography (according to assessment of the local investigators)
- •NYHA class II-IV
- •Symptoms of heart failure ≥ 6 months
- •Treatment with guideline-directed medical therapy (GDMT) for ≥6 months and stable dose of ACEI/ARB/ARNI/β-blocker/SGLT2i/MRA/sGCa for ≥1 month (excluding diuretics)
- •Hemodynamically stable
- •Informed consent
排除标准
- •ICD implantation < 1 month or CRT/D implantation < 6 months
- •Heart failure caused by other heart diseases
- •End-stage heart failure, inability to discontinue intravenously positive inotropic or vasoactive drugs
- •Expected survival < 1 year
- •Hemoglobin < 90g/L
- •Any disease requiring immunosuppressive drugs
- •Commodities with other acute or severe illnesses, such as infections, severe hepatic or renal dysfunction, hematological diseases, malignant tumors, cachexia, autoimmune diseases, etc.
- •Previous treatment with immunoadsorption therapy or intravenous immunoglobulin therapy
- •Contraindications to extracorporeal circulation therapy, such as mental illness or consciousness disorders, shock, severe bleeding or bleeding tendency, coagulation dysfunction, multiple organ failure, etc.
- •Pregnancy/lactation
- •Any other conditions that the researcher deems may increase the risk to the subject or interfere with the clinical trial and outcome assessment (such as excessive anxiety, alcohol or drug abuse, or cognitive impairment, etc.)
结局指标
主要结局
Change in LVEF from baseline to 6 months determined by echocardiography
时间窗: From enrollment to follow-up at 6 months
次要结局
- LVEF as determined by echocardiography at baseline and after 3, 12 and 24 months(From enrollment to follow-up at 24 months)
- NT-proBNP at baseline and after 3, 6, 12 and 24 months(From enrollment to follow-up at 24 months)
- LVEDD and LVESD as determined by echocardiography at baseline and after 3, 6, 12 and 24 months(From enrollment to follow-up at 24 months)
- NYHA classification at baseline and after 3, 6, 12 and 24 months(From enrollment to follow-up at 24 months)
- Kansas City Cardiomyopathy Questionnaire (KCCQ) score at baseline and after 3, 6, 12 and 24 months(From enrollment to follow-up at 24 months)
研究者
Xiang Cheng
Professor
Wuhan Union Hospital, China
研究点 (1)
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