Clinical trial NCT02202902: Cardiac Steatosis in Cushing's Syndrome
Official title: Evaluation of Cardiac Steatosis in Cushing's Syndrome. A 1H-Magnetic Resonance Spectroscopy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Endocrine System Disease
Cardiovascular Imaging
Keywords: Cushing's syndrome
cardiac steatosis
intramyocardial triglyceride content
1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging
Left Ventricularly hypertrophy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging, in patients with Cushing's syndrome before and after treatment and in age-, sex- and BMI-matched healthy volunteers. The investigators make the hypothesis that Cushing's syndrome patients compared to healthy subjects present with excess lipid storage in cardiac myocytes, reversible upon correction of hypercortisolism.

Detailed description: Despite skeletal muscle atrophy, Cushing's syndrome patients have an increased Left Ventricular mass, reversible upon correction of the hypercortisolism. This may be due to cardiac steatosis, previously demonstrated in patients with diabetes mellitus. This study aims at evaluating the myocardial triglyceride content and cardiac structure and function, using 1H magnetic resonance spectroscopy and cardiac magnetic resonance imaging (CMRI), in patients with Cushing's syndrome and in age-, sex- and BMI-matched healthy volunteers. The patients will be stratified into two groups in function of the presence or absence of diabetes mellitus or impaired glucose and will be evaluated twice: before and 6 months after efficient treatment of Cushing's syndrome. We make the hypothesis that Cushing's syndrome patients compared to healthy subjects have excess lipid storage in cardiac myocytes irrespectively of the glucose homeostasis status, and that this lipid content will decrease after the correction of hypercortisolism.

Eligibility criteria: Inclusion Criteria:

* group 1 and 2: patients with overt Cushing's syndrome, with 24-hour urinary free cortisol excretion over the two fold of the upper limit of the normal, with (group 1) or without (group 2) diabetes mellitus or glucose intolerance
* group 3: healthy volunteers matched for age, sex and BMI with the patients of the group 2

Exclusion Criteria:

* contraindication of MRI
* hypersensitivity to gadolinium
* acute myocardial ischemia
* renal insufficiency (creatinin clearance 30 mL/min/l,73m2)
* pregnancy

Primary outcomes:
measure: Left Ventricular (LV) intramyocardial triglyceride / water ratio LV intramyocardial triglyceride / water ratio
timeFrame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Secondary outcomes:
measure: Left Ventricular intramyocardial fatt fraction (Dixon)
timeFrame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
measure: Subcutaneous and visceral abdominal fatt
timeFrame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
measure: Cardiac morphology and function
timeFrame: Assessed twice in patients - before and 6 months after treatment - and once in volunteers
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: AP-HP, Bicêtre Hospital
name: Philippe CHANSON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wolf P, Marty B, Bouazizi K, Kachenoura N, Piedvache C, Blanchard A, Salenave S, Prigent M, Jublanc C, Ajzenberg C, Droumaguet C, Young J, Lecoq AL, Kuhn E, Agostini H, Trabado S, Carlier PG, Feve B, Redheuil A, Chanson P, Kamenicky P. Epicardial and Pericardial Adiposity Without Myocardial Steatosis in Cushing Syndrome. J Clin Endocrinol Metab. 2021 Nov 19;106(12):3505-3514. doi: 10.1210/clinem/dgab556.