NCT05911620

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Oct 2023Aug 2026

First Submitted

Initial submission to the registry

May 2, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

October 24, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

October 25, 2023

Status Verified

October 1, 2023

Enrollment Period

2.4 years

First QC Date

May 2, 2023

Last Update Submit

October 24, 2023

Conditions

Cushing SyndromeMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Evaluation of the presence of hepatic fibrosis by MRE (kPa).

    Baseline (day 0)

  • Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).

    Baseline (day 0)

  • Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).

    Baseline (day 0)

  • Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).

    Baseline (day 0)

  • Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).

    Baseline (day 0)

  • +7 more secondary outcomes

Study Arms (3)

Cushing's Syndrome

EXPERIMENTAL

Patients with proven autonomic cortisol secretion (Cushing's Syndrome)

Device: Magnetic resonance elastography (MRE)

Suspected Cushing's Syndrome

EXPERIMENTAL

Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)

Device: Magnetic resonance elastography (MRE)

Metabolic Syndrome

ACTIVE COMPARATOR

Patients with metabolic syndrome

Device: Magnetic resonance elastography (MRE)

Interventions

Magnetic resonance elastography (MRE)DEVICE

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

Cushing's SyndromeMetabolic SyndromeSuspected Cushing's Syndrome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Nancy, France

RECRUITING

MeSH Terms

Conditions

Cushing SyndromeMetabolic Syndrome

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Adrenocortical HyperfunctionAdrenal Gland DiseasesEndocrine System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Nicolas SCHEYER, MD

CONTACT

+33383154302n.scheyer@chru-nancy.fr

Guillaume DROUOT, PhD

CONTACT

+33383157666g.drouot@chru-nancy.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2023

First Posted

June 22, 2023

Study Start

October 24, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

October 25, 2023

Record last verified: 2023-10

Locations

FR(1)