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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05911620
Other study ID # 2022-A01786-37
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 24, 2023
Est. completion date August 31, 2026

Study information

Verified date October 2023
Source Central Hospital, Nancy, France
Contact Nicolas SCHEYER, MD
Phone +33383154302
Email n.scheyer@chru-nancy.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main hypothesis of the HEPACORT study is that upon diagnosis of endogenous Cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of Cushing's syndrome. the HEPACORT study is the first exploratory study to assess the severity of liver fibrosis in patients with Cushing's syndrome or suspected of presenting by Magnetic Resonance Elastography (MRE).


Recruitment information / eligibility

Status Recruiting
Enrollment 21
Est. completion date August 31, 2026
Est. primary completion date February 28, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age = 18 years old; - Person affiliated to a social security scheme or beneficiary of such a scheme; - Person having received complete information on the organization of the research and having signed informed consent; - Person having carried out a preliminary clinical examination adapted to the research. - Patients with Cushing's syndrome (for the Cushing's Syndrome group) - Patients with possible Cushing's syndrome (for the suspected Cushing's Syndrome group) defined as response to the dexamethasone supression test with 1 mg of Dexamethasone, with a plasma cortisol assay at 8 am between 18 and 50 µg/L carried out in the 3 months preceding ; - Patients with metabolic syndrome (for the metabolic syndrome group) Exclusion Criteria: - Person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion; - Person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion; - Person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion; - Person with chronic liver disease; - Person with alcohol misuse, defined by a weekly consumption of more than 10 standard units; - Person with a morphotype that does not allow an MRI examination to be performed; - Woman of childbearing age who does not have an effective means of contraception; - Contraindication to performing an MRI examination. - Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.

Study Design


Intervention

Device:
Magnetic resonance elastography (MRE)
Magnetic Resonance Imaging (MRI) imaging with low-frequency vibrations to create a visual map (elastogram) that shows stiffness of body tissues

Locations

Country Name City State
France CHRU Nancy Nancy

Sponsors (1)

Lead Sponsor Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Estimation of the severity of hepatic fibrosis by MRE (kPa). Estimation of the severity of hepatic fibrosis in kPa by a non-invasive elastography method : magnetic resonance elastography. Baseline (day 0)
Secondary Evaluation of the presence of hepatic fibrosis by MRE (kPa). Evaluation of the presence of hepatic fibrosis by ERM : ERM value = 72.5 kPa. Baseline (day 0)
Secondary Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa). Baseline (day 0)
Secondary Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa). Baseline (day 0)
Secondary Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa). Baseline (day 0)
Secondary Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa). Baseline (day 0)
Secondary Evolution of transaminases (UI/L) between the diagnosis and the last visit. 1 year
Secondary Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit. 1 year
Secondary Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit 1 year
Secondary Evolution of Bilirubin (mg/L) between the diagnosis and the last visit. 1 year
Secondary Evolution of Albumin (g/L) between the diagnosis and the last visit. 1 year
Secondary Evolution of platelets (platelets/mm3) between the diagnosis and the last visit. 1 year
Secondary Evolution of ferritin (ng/mL) between the diagnosis and the last visit. 1 year
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