Phase III Study of Intravenous Immunglobulin (IVIG) in Patients With Heart Failure After Myocardial Infarction
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- 1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI
研究概览
简要总结
The instigators hypothesize that IVIG, given in the acute phase following MI in patients at risk for developing HF, will improve cardiac performance, and by attenuating cardiac remodeling in this phase, such therapy will prevent the development of chronic HF resulting in long term beneficial effect also after the therapy has been stopped.
详细描述
This double-blind placebo-controlled study represents a new approach to cardiovascular disease. The project deals with unresolved issues in the intersection between cardiology, immunology and molecular biology.
IVIG/placebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months. Change in left ventricular remodeling will be assessed at baseline, and 6 and 12 months with MRI and echocardiography.
The objectives are:
- The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function: LV remodeling will be evaluated with magnetic resonance imaging (MRI) which offers an unsurpassed precision in the measurements of heart volumes and function. End points will be LV-end systolic and diastolic volume (LVESV, LVEDV), regional wall motion score index (WMSI), and LV-ejection fraction (LV-EF).
- The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide (BNP). BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20.
- The tertiary objective of this study is to evaluate the effect on IVIG on:
a. Quality of life. b. Effect on New York Heart Association (NYHA) functional class. c. Effect on immunological variables. i. Inflammatory cytokines such as TNF-alpha, IL-6, IL-18. ii. Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii. Chemokines such as monocyte chemoattractant protein 1, IL-8 and CCL21. iv. Regulators of hypertrophy such as matrix metalloproteinases, their endogenous inhibitors (i.e., TIMPs) and procollagen III N-terminal.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 18 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18-80 years
- •Have a recent MI (<5days)
- •Have ASAT >100 U/L or CKMB > 50 U/L.
- •Have LVEF <40%.
- •Are on optimal medical treatment and considered unsuitable for surgical intervention.
排除标准
- •Evidence of unstable disease, concomitant ischemia or unstable angina during the hospitalization.
- •Significant concomitant disease such as infections, pulmonary disease or connective tissue disease.
- •Participating in other studies.
- •Inability to participate.
- •Diseases that require surgery.
- •Planned revascularisation.
- •Known hypersensitivity to IVIG.
研究组 & 干预措施
Saline
干预措施: Octagam (IVIG) (Drug)
Octagam (IVIG)
Octagam (IVIg) is intravenous immunglobulin
干预措施: Octagam (IVIG) (Drug)
结局指标
主要结局
1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI
时间窗: 2009
次要结局
- 2. Effect on IVIG on B-Type Natriuretic Peptide (BNP).(2009)
研究者
Lars Gullestad
Professor
Oslo University Hospital