Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa

NCT03600610 | Unknown

• 1 other identifier: 2018-22
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anorexia Nervosa; Cardiac Anomaly

Outcome Measures

Primary Outcomes (1)

• Diffuse myocardial fibrosis

  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

  45 minutes

Secondary Outcomes (3)

• Local myocardial fibrosis

  45 minutes

• Myocardial triglycerides quantification

  1hour

• Cardiac metabolism

  1day

Study Arms (2)

patient group

EXPERIMENTAL

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

Device: gadolinium-enhanced cardiac MRI

control group

ACTIVE COMPARATOR

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

Device: gadolinium-enhanced cardiac MRI

Interventions

gadolinium-enhanced cardiac MRI DEVICE

cardiac magnetic resonance imaging with gadolinium injection used T1-Mapping

control group; patient group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Pubique Des Hopitaux de Marseille

Marseille, PACA, 13354, France

Location

MeSH Terms

Conditions

Anorexia Nervosa; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• EMILIE GARRIDO PRADALIE

  APHM

  STUDY DIRECTOR

Central Study Contacts

patrice DARMON, MD

CONTACT

04 91 38 36 53; patrice.darmon@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 26, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: March 1, 2020
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

FR (1)