Evaluation of Myocardial Iron Deposition in Patients of Heart Failure Using T2* MR Imaging
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- T2* Values
研究概览
简要总结
Heart failure from myocardial iron deposition is a severe complication for patients with hematological disorders who need repeated blood transfusions. Increased cardiac iron content impacts the contractility of cardiomyocytes and can also lead to myocarditis, pericarditis, and arrhythmias. The severity of cardiac dysfunction depends on the amount of iron deposited in the myocardium.
Cardiovascular magnetic resonance (CMR) imaging is used as noninvasive method to evaluate the amount of iron in the heart. Myocardial T2* value has been shown to correlate well with biopsy-derived iron concentration in the heart, and myocardial T2* values less than 20ms (indicating elevated iron) were found to be associated with LV dysfunction and improve in concert with LV function during recovery. The majority of the recent studies about myocardial iron overload and the effect of iron chelation therapy were focused on patients with transfusion-dependent hematological disorder, especially beta-thalassemia major.
The objective of this 3-year project is to evaluate myocardial iron deposition in patients with heart failure, induced by variable causes. With myocardial T2* imaging, the investigators will analyze the decreased signal intensity in the ventricular septum and quantitatively acquire the T2* value as marker for myocardial iron deposition. The first year is a cross-sectional study. The investigators aim to compare the severity of myocardial iron deposition of normal subjects and that of stable HF patients in recovery with normal or impaired ejection fraction (EF). Total 60 subjects will be enrolled, with 20 subjects in each group. In the 2nd and 3rd years, the investigators plan a prospective longitudinal study of 40 subjects. Enrolled patients will be evaluated with cardiac T2* imaging at three time points, i.e., disease onset, 6 months and one year after treatment, and will be followed up until the end of this project (1.5~3-year follow up). In total 120 MR scans will be performed in the 2nd and 3rd years. The presence and severity of myocardial iron deposition will be correlated with the disease course, patient biochemistry data and clinical outcome.
详细描述
Introduction
Heart failure (HF) is a complex clinical syndrome resulting from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood. In Taiwan, HF is a growing epidemic, owing to the aging population and the increasing survival of patients presenting with acute myocardial infarction and various other heart diseases. The reported 5- and 10-year mortality ranged from 14% and 48.2% in those with impaired LVEF versus 14.1% and 24.4% in those with pre- served LVEF, respectively.
The diagnosis of HF is based on symptoms typical of heart failure, and signs typical of heart failure and an objective evidence structural or functional abnormality of the heart. Asymptomatic structural or functional abnormalities of the heart (myocardial remodeling) are usually progressive disorders and are considered as precursors of symptomatic heart failure. Therefore early diagnosis of the underlying etiology and cause should always be sought for guiding a suitable and preventive treatment.
Myocardial iron deposition leads to progressive heart dysfunction and is thought to be a leading cause of death in transfusion-dependent anemia. Endomyocardial biopsy, which has been used to evaluate iron deposition in the heart, is risky and has unacceptable sampling variability. Non-invasive MR scanning is currently the imaging method shown to be reliable and accurate to assess myocardial iron loading. The application of the MR transverse relaxation times T2* has been successfully demonstrated for quantitative assessment of the iron concentration in the heart.
Purpose The objective of this project is to evaluate myocardial iron deposition in patients with heart failure (HF). Deposition of iron on the myocardium is expected to be found in patients with heart failure induced by other cause rather than transfusion-dependent hematological disorder. In this longitudinal study, we will attempt to analyze the presence and severity of myocardial iron deposition, variation along the course and correlate with clinical outcome in patients with HF.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •heart failure patients diagnosed in the Keelung Chang Gung Memorial Hospital
- •patients must be ≥ 20 and ≤ 70 years of age
- •patients must be willing to undergo standard treatment and follow up in the Heart Failure Center
- •patients must be able to give informed consent.
排除标准
- •patients who are judged to be noncompliant to treatment or not accessible for follow up
- •patients with contraindications to MR scanning, such as claustrophobia, cardiac pacemaker, metal implants, or unable to cooperate for MRI study due to mental status
- •Severe renal function impairment (glomerular filtration rate less than 30 mL/min/1.73m2)
- •pregnant or breast-feeding
- •history of open-heart surgery
结局指标
主要结局
T2* Values
时间窗: 12 months
次要结局
未报告次要终点