NCT01877746Unknown3 期
RANDOMIZED, MULTICENTRIC STUDY COMPARING THE EFFECT OF TWO REGIMENS OF COMBINED IMMUNOSUPPRESSIVE THERAPY IN THE TREATMENT OF INFLAMMATORY CARDIOMYOPATHY CZECH-ICIT (CZECH INFLAMMATORY CARDIOMYOPATHY IMMUNOSUPPRESSION TRIAL)
St. Anne's University Hospital Brno, Czech Republic2 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 234
- 试验地点
- 2
- 主要终点
- comparison of the change in LV ejection fraction
研究概览
简要总结
The aim of this study is to compare the effect of combined immunosuppressive therapy given on the top standard medical therapy of chronic heart failure according to current guidelines with standard medical therapy of chronic heart failure alone in patients with infammatory cardiomyopathy (ICM).
Suitable subjects are characterized by EMB established presence of myocardial inflammation / negative polymerase chain reaction assay (PCR) findings of cardiotropic infectious agents and with varying duration of heart failure symptoms and left ventricular (LV) systolic dysfunction (phase A).
Further, to compare the effect of two regimens of combined immunosuppressive therapy in these patients with ICM (phase B).
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females aged 18 to 65 years at the time of signing the informed consent
- •Signing of the informed consent.
- •LV systolic dysfunction defined by ejection fraction less than/or equal 40% as assessed by echocardiography and symptoms of heart failure (minimum NYHA class II) lasting for at least 2 weeks at the time of randomization. This criterion also determines the inclusion of the study subjects in one of two substudies (CZECH-ICIT 1 or CZECH-ICIT 2).
- •LV systolic dysfunction (defined by ejection fraction less than/or equal 40%) and symptoms of heart failure (minimum NYHA class II) lasting 2 weeks to 6 months, with standard medical therapy of chronic heart failure given for at least 2 weeks - the subject fulfills criterion for inclusion in CZECH-ICIT 1 substudy
- •LV systolic dysfunction (defined by ejection fraction less than/or equal 40%) and symptoms of heart failure (minimum NYHA class II) lasting more than 6 months, with standard medical therapy of chronic heart failure given for at least 2 weeks - the subject fulfills criterion for inclusion in CZECH-ICIT 2 substudy
- •Positive immunohistochemistry finding of myocardial inflammation in endomyocardial biopsy (EMB). EMB must have been be performed no more than 6 weeks prior to the inclusion in the study. Positive immunohistochemistry EMB finding demonstrating myocardial inflammation is defined by the presence of at least 7/mm2 cluster of differentiation 3 (CD3) positive lymphocytes and/or at least 14 infiltrating leucocytes (LCA+ cells)/mm2 in the specimen.
- •The absence of infectious agent in EMB is defined by negative results of PCR testing of EMB specimens. PCR testing will be aimed to exclude the presence of enteroviruses (ECHO, coxsackie), adenoviruses, herpes viruses (herpes simplex virus (HSV-1), Epstein-Barr virus (EBV), cytomegalovirus (CMV), human herpes virus (HHV-6)), Borrelia burgdorferi and parvovirus B
- •In the case of parvovirus B19, a negative PCR result will be considered when less than 500 viral copies/ug genomic DNA are detected. EMB must have been performed no more than 6 weeks prior to the inclusion in the study.
- •Negative blood pregnancy test in fertile females.
- •Usage of the effective method of contraception (hormonal or 2 barrier method of contraception)
排除标准
- •The presence of coronary artery disease, defined by angiographic findings of one or more coronary artery stenosis > 50%, history of previous myocardial infarction and/or percutaneous or surgical myocardial revascularization. Coronary angiography must not have been performed more than 2 years before randomization into the study.
- •Permanent pacemaker including cardiac resynchronization therapy.
- •The presence of uncontrolled, persistent supraventricular tachyarrhythmia, with ventricular rate > 120/min, lasting more than 1 week before EMB.
- •The presence of uncontrolled arterial hypertension, defined by blood pressure values > 180mmHg (for systolic pressure) and/or 110mmHg (for diastolic pressure) lasting more than 3 months.
- •The presence of at least moderately hemodynamically significant primary valvulopathy or congenital heart disease (apart from patent foramen ovale and non-significant atrial septal defect).
- •Previous heart valve surgery (replacement or reconstruction) or surgical correction of congenital heart disease. adu.
- •A history of cytostatic therapy or radiotherapy.
- •Alcoholism defined as ethanol intake >90 g/day.
- •The presence of uncontrolled endocrine of metabolic disorder.
- •Gravidity and lactation.
- •Known hypersensitivity to investigational drugs.
- •All contraindications of immunosuppressive therapy according to Summary of product characteristics (SmPC) of both investigational medicinal products: untreated systemic infection, poorly manageable diabetes mellitus, osteoporosis, florid gastric or duodenal ulcer, uncontrolled arterial hypertension, history of malignant disease with oncological treatment finished less than 5 years, proven immunodeficiency, renal of hepatic insufficiency (serum creatinine > 200 µmol/l; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) activity greater than three times the standard), leukocytopenia (leucocytes less than 4 x 10 9/l), thrombocytopenia (platelets less than 100 x 10 9/l), anemia (hemoglobin concentration less than 100 g/l).
研究组 & 干预措施
R1 - combined immunosuppressive therapy
Experimental
application of the combined immunosuppressive therapy in the first dosing regimen
干预措施: Combination of prednisone and azathioprine (Drug)
R2 - combined immunosuppressive therapy
Experimental
application of the combined immunosuppressive therapy in the second dosing regimen
干预措施: Combination of prednisone and azathioprine (Drug)
S - standard therapy
Other
only standard medical therapy of chronic heart failure without application of the combined immunosuppressive therapy
干预措施: No intervention (Other)
结局指标
主要结局
comparison of the change in LV ejection fraction
时间窗: baseline and in 12 months after the initiation of immunosuppressive therapy
次要结局
- comparison of total mortality(baseline and in 12 months after the initiation of immunosuppressive therapy)
- comparison of the combined end-point(baseline and in 12 months after the initiation of immunosuppressive therapy)
- comparison of the change of LV end-diastolic and end-systolic diameters(baseline and in 12 months after the initiation of immunosuppressive therapy)
- comparison of the change of New York Heart Association (NYHA) class(baseline and in 12 months after the initiation of immunosuppressive therapy)
- comparison of the change in the number of infiltrating inflammatory cells in EMB(baseline and in 12 months after the initiation of immunosuppressive therapy)
研究者
Jan Krejci, MD, Ph.D
MD, Ph.D
St. Anne's University Hospital Brno, Czech Republic
研究点 (2)
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