Immunoglobulin Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Parvovirus B19 Persistence - a Prospective, Double-blind, Randomized, Placebo-controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.
研究概览
简要总结
A prospective randomized double-blind placebo-controlled trail to investigate the effect of high doses of IVIg on cardiac functional capacity and virus presence in a subgroup of patients with chronic symptomatic ICM and a high PVB19 load in the heart.
详细描述
Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to idiopathic cardiomyopathy.
Objective
A controlled trial to investigate whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy in patients with idiopathic cardiomyopathy and PVB19 persistence in the heart achieves improvement of cardiac function in conjunction with virus elimination.
Study design: All patients will undergo routine diagnostic work-up (including physical examination, coronary angiogram, transthoracic echocardiogram, blood studies and endomyocardial biopsies (EMB)), treatment and follow-up for their heart failure. Patients will be randomized to either receive IVIg or placebo on top of their standard heart failure regimen.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Idiopathic cardiomyopathy (LVEF <45%) >6months
- •Optimal conventional heart failure medication >3 months.
- •PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies (EMBs).
- •Signed informed consent
- •Aged between 18 and 75 years
排除标准
- •Other causes for heart failure
- •Significant coronary artery disease (lesions >70 % stenosis)
- •Significant valvular disease
- •Untreated hypertension (blood pressure >140mmHg)
- •Substance abuse
- •Chemotherapy induced
- •Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
- •Pregnancy or lactation
- •Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
- •Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- •Known with allergic reactions against human plasma or plasma products
- •Having an ongoing progressive terminal disease, including HIV infection
- •Having renal insufficiency (plasma creatinin >115µmol/L or creatinin clearance <20 ml/min)
- •Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints
- •Having detectable anti-IgA antibodies
- •Active SLE
研究组 & 干预措施
intravenous immunoglobulins
IV, 40 ml/kg over 4 days
干预措施: Intravenous Immunoglobulins (Drug)
plasma volume expander Albuman
IV, 40 ml/kg over 4 days
干预措施: plasma volume expander (Drug)
结局指标
主要结局
The main study parameter is the change in cardiac ejection fraction presence of the heart from baseline to endpoint.
时间窗: 6 months
次要结局
- Secondary objectives include changes in presence of cardiotrophic viruses, inflammation , fibrosis, cardiac functional capacity, patient quality of life, other echocardiographic parameters.(6 months)