Cardiac Steatosis in Cushing's Syndrome (CORTICOEUR)

Assistance Publique - Hôpitaux de Paris

Status: Unknown

Conditions: Cardiovascular Imaging; Endocrine System Disease

Treatments: Other: 1H magnetic resonance spectroscopy and CMRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02202902

2013-A01023-42 (Other Identifier)

AOR12017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 3 patient groups

Group 1 : 1H magnetic resonance spectroscopy and CMRI

Experimental group

Description:

Group 1 : Cushing's syndrome patients with diabetes mellitus or glucose intolerance

Treatment:

Other: 1H magnetic resonance spectroscopy and CMRI

Other: 1H magnetic resonance spectroscopy and CMRI

Group 2 : 1H magnetic resonance spectroscopy and CMRI

Experimental group

Description:

Group 2: Cushing's syndrome patients with normal glucose intolerance

Treatment:

Other: 1H magnetic resonance spectroscopy and CMRI

Other: 1H magnetic resonance spectroscopy and CMRI

Group 3 : 1H magnetic resonance spectroscopy and CMRI

Experimental group

Description:

age-, sex- and BMI-matched healthy volunteers

Treatment:

Other: 1H magnetic resonance spectroscopy and CMRI

Other: 1H magnetic resonance spectroscopy and CMRI