Anorexia NervosaCARERANCT03600610
Evaluation of CARdiac Abnormalities by Echocardiography and MRI in Malnourished Patients Suffering From Anorexia Nervosa
A study testing gadolinium-enhanced cardiac MRI in people with Anorexia Nervosa and Cardiac Anomaly, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa, Cardiac Anomaly
- What is being tested?
- gadolinium-enhanced cardiac MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2018to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Pubique Des Hopitaux de Marseille
Marseille, PACA, 13354
PATRICE DARMON, MD, 04 91 38 36 53, patrice.darmon@ap-hm.fr
About this study
Official title: Evaluation of CARdiac Morphological and Functional Abnormalities by Echocardiography and Magnetic Resonance Imaging in Malnourished Patients Suffering From Anorexia Nervosa
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.
Read the detailed description
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.
- Conditions
- Anorexia Nervosa, Cardiac Anomaly
- Being tested
- gadolinium-enhanced cardiac MRI
- Medical subject headings
- Anorexia Nervosa, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gadolinium-enhanced cardiac MRIDevice
cardiac magnetic resonance imaging with gadolinium injection used T1-Mapping
| Study group | Role | What they receive |
|---|---|---|
| patient group | Experimental | malnourished patients with anorexia nervosa gadolinium-enhanced cardiac MRI will be performed Receives: Device: gadolinium-enhanced cardiac MRI |
| control group | Active comparator | age- and sex- matched, normal weight, healthy volunteers gadolinium-enhanced cardiac MRI will be performed Receives: Device: gadolinium-enhanced cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 45 minutes
Secondary outcomes (3)
Local myocardial fibrosis
Cardiac MRI (Late Gadolinium enhancement) Nodular myocardial fibrosis will be measured using late gadolinium enhancement after DOTAREM-gadolinium single dose injection (0.1 mmol / kg)
Measured: 45 minutes
Myocardial triglycerides quantification
quantification by Proton spectroscopy A T1 contrast sequence is used with a set of small-axis sections (n = 14) covering the entire heart for evaluation of pericardial adipose tissue volume
Measured: 1hour
Cardiac metabolism
Phosphore-31 spectroscopy It will be evaluated by spectroscopy of phosphorus 31 (SRM-P31) with the study of phosphocreatine / adenosine triphosphate ratio
Measured: 1day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startSep 2018 (estimated)
- Primary completionSep 2019 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- EMILIE GARRIDO PRADALIE, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600610
- Sponsor's protocol ID
- 2018-22
- Acronym
- CARERA
- Status last verified
- Jul 2018
- First submitted
- 17 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of CARdiac Morphological and Functional Abnormalities by Echocardiography and Magnetic Resonance Imaging in Malnourished Patients Suffering From Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03600610
- Acronym / sponsor ID
- CARERA / 2018-22
- Conditions
- Anorexia Nervosa, Cardiac Anomaly
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 26 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient group | Experimental | Device: gadolinium-enhanced cardiac MRImalnourished patients with anorexia nervosa gadolinium-enhanced cardiac MRI will be performed |
| control group | Active comparator | Device: gadolinium-enhanced cardiac MRIage- and sex- matched, normal weight, healthy volunteers gadolinium-enhanced cardiac MRI will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gadolinium-enhanced cardiac MRIcardiac magnetic resonance imaging with gadolinium injection used T1-Mapping | Device | control group, patient group |
Primary outcome
Diffuse myocardial fibrosis
Time frame: 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
3 secondary outcomes
Local myocardial fibrosis
Time frame: 45 minutes
Myocardial triglycerides quantification
Time frame: 1hour
Cardiac metabolism
Time frame: 1day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
EMILIE GARRIDO PRADALIE study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gadolinium-enhanced cardiac MRI in people with Anorexia Nervosa and Cardiac Anomaly, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact patrice DARMON, MD (04 91 38 36 53, patrice.darmon@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffuse myocardial fibrosis (time frame: 45 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2018.