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临床试验/NCT03600610
NCT03600610Unknown不适用

Evaluation of CARdiac Morphological and Functional Abnormalities by Echocardiography and Magnetic Resonance Imaging in Malnourished Patients Suffering From Anorexia Nervosa

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2018年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
76
试验地点
2
主要终点
Diffuse myocardial fibrosis

研究概览

简要总结

Anorexia nervosa is an eating disorder occurring in adolescent females, characterized by voluntary dietary restriction, intense fear of gaining weight, and disturbed body image perception. Anorexia nervosa is characterized by the potential severity of its prognosis. While complete remission occurs in about 50% of cases, up to 20% of patients will develop a chronic relapsing form that leads to social disintegration. Moreover, anorexia nervosa has the highest mortality rate among psychiatric diseases with a risk of death of up to 10%. 30% of deaths in anorexia nervosa are attributed to cardiac complications remaining insufficiently described, and their screening at a preclinical stage is still poorly codified. Echocardiography findings show reduced left ventricular mass, pericardial effusion or mitral valve prolapse ; in addition, systolic function appears to be preserved whereas a global diastolic dysfunction, estimated with trans-mitral flow and global longitudinal strain. While the interest of cardiac echography has been well established, only one study used MRI as a means of cardiac evaluation in anorexia nervosa: interestingly, local myocardial fibrosis is pointed and could potentially contribute to cardiac rhythm disorders. No study has yet used T1-Mapping MRI to evaluate if diffuse myocardial fibrosis is prevalent in this population group.

The investigators conduct a transversal, observational, monocentric study whereby malnourished patients with anorexia nervosa and age- and sex- matched, normal weight, healthy volunteers will undergo a gadolinium-enhanced cardiac MRI. The primary objective of this study is to evaluate and compare the frequency of cardiac fibrosis in those populations. Other cardiac MRI parameters will be described and compared as secondary objectives. Moreover, non-cardiac parameters evaluated by MRI such as adipose tissue distribution in anorexia nervosa patients compared with controls.

In addition, patients with anorexia nervosa, a clinical, morphological and biological evaluation, including anthropometric parameters, biphotonic absorptiometry, resting electrocardiogram, cardiac echography and classical biological markers of malnutrition, will be done.

详细描述

Anorexia nervosa is an eating disorder occurring most frequently in adolescent females, characterized by 1/ voluntary dietary restriction, leading to lower than normal body weight and, often, loss of considerable amount of weight and, thereby, malnutrition, 2/ intense fear of gaining weight, even when the individual is already underweight, starved or malnourished and 3/ disturbed body image perception, including extreme emphasis on the appearance. Anorexia nervosa is characterized by the potential severity of its prognosis. While complete remission occurs in about 50% of cases, up to 20% of patients will develop a chronic relapsing form that leads to social disintegration. Moreover, anorexia nervosa has the highest mortality rate among psychiatric diseases with a risk of death of up to 10% (including suicide and clinical complications of severe malnutrition). If approximatively 30% of deaths in anorexia nervosa are attributed to cardiac complications, the nature and the frequency of such complications remain insufficiently described, and their screening at a preclinical stage is still poorly codified. Echocardiography findings are well documented and include reduced left ventricular mass, pericardial effusion (in 22 to 35% of cases), or mitral valve prolapse (in up to 35% of cases); in addition, systolic function, evaluated by the ejection fraction appears to be preserved whereas a global diastolic dysfunction, estimated with trans-mitral flow and global longitudinal strain, is reported. While the interest of cardiac echography has been well established, only one study used MRI (magnetic resonance imaging) as a means of cardiac evaluation in anorexia nervosa: interestingly, this study found local myocardial fibrosis in nearly 25% of patients with anorexia nervosa, which could potentially contribute to cardiac rhythm disorders. That said, no study has yet used T1-Mapping MRI to evaluate if diffuse myocardial fibrosis is prevalent in this population group.

The investigators aim to conduct a transversal, observational, monocentric study whereby malnourished patients with anorexia nervosa (n = 38) and age- and sex- matched, normal weight, healthy volunteers (n = 38) will undergo a gadolinium-enhanced cardiac MRI. The primary objective of this study is to evaluate and compare the frequency of cardiac fibrosis in those populations using cardiac MRI. Other morphological and functional cardiac MRI parameters will be described and compared as secondary objectives: local myocardial fibrosis using enhanced MRI; myocardial and left ventricular mass; myocardial triglyceride quantification using Proton spectroscopy; cardiac high-energy metabolism using Phosphore-31 spectroscopy. Moreover, non-cardiac parameters evaluated by MRI such as adipose tissue distribution (visceral fat, liver fat, bone marrow fat) in anorexia nervosa patients compared with controls.

In addition, patients with anorexia nervosa, a clinical, morphological and biological evaluation, including anthropometric parameters, biphotonic absorptiometry, resting electrocardiogram, cardiac echography and classical biological markers of malnutrition, will be done. Multivariate analysis will then be used to identify possible correlating factors between cardiac MRI findings and clinical, morphological and biological parameters in malnourished patients with anorexia nervosa, so as to shed light on possible new risk stratification models or predictive tools for cardiac complications that could be later evaluated by appropriate studies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years old
  • Anorexia nervosa as defined by DSM-V with BMI < 15kg/m²
  • Healthy controls with BMI within 18 to 25 kg/m²

排除标准

  • History of cardiac disease previous to the diagnosis of anorexia nervosa
  • On-going pregnancy or previous 3 month
  • Breast feeding
  • RMI contraindication
  • History of allergic reaction to contrast product

研究组 & 干预措施

patient group

Experimental

malnourished patients with anorexia nervosa gadolinium-enhanced cardiac MRI will be performed

干预措施: gadolinium-enhanced cardiac MRI (Device)

control group

Active Comparator

age- and sex- matched, normal weight, healthy volunteers gadolinium-enhanced cardiac MRI will be performed

干预措施: gadolinium-enhanced cardiac MRI (Device)

结局指标

主要结局

Diffuse myocardial fibrosis

时间窗: 45 minutes

Cardiac MRI (T1 Mapping shMOLLI) Diffuse myocardial fibrosis will be measured using ShMOLLI type T1 mapping methods to obtain high-resolution maps in the heart and a quantitative measure of fibrosis

次要结局

  • Local myocardial fibrosis(45 minutes)
  • Myocardial triglycerides quantification(1hour)
  • Cardiac metabolism(1day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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