Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome) (CV-CORT-EX)

W

Wuerzburg University Hospital

Status

Completed

Conditions

Endogenous Cushing's Syndrome

Treatments

Diagnostic Test: Cardiovascular status and quality of life

Study type

Observational

Funder types

Other

Identifiers

NCT03880513
CV-CORT-EX

Details and patient eligibility

About

Within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated.

Full description

Endogenous Cushing's syndrome (CS) is associated with increased cardiovascular (CV) morbidity and reduced general health status. It has been shown that these impairments may be reversible after cure of hypercortisolism. However, previous studies were restricted to selected CV aspects. The primary aim of the CV-CORT-EX study is to comprehensively assess left ventricular function and morphology of patients with endogenous CS. Secondly, we examine long-term changes of CV function, endothelial function, psychosocial status, bio-impedance, and quality of life. Within the longitudinal study, patients will be investigated at initial diagnosis and at least 6 months after cure of CS. Within the cross-sectional study, we aim to comprehensively phenotype patients with endogenous CS and unknown CV disease. Results will finally be compared with healthy controls.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Written informed consent
  • Age ≥18 years
  • Cross-sectional study:History of clinically and biochemically proven endogenous Cushing's syndrome (overt or subclinical)
  • Longitudinal study: Patients with clinically and biochemically proven endogenous Cushing's syndrome (initial diagnosis or recurrent disease)

Exclusion criteria

  • Glucocorticoid pharmacotherapy for >12 months within the previous 3 years
  • Structural heart disease, chronic heart failure (>NYHAII), systemic or single organ disease potentially affecting cardiac function
  • Arterial hypertension (uncontrolled with >3 antihypertensive drugs)
  • Pregnancy
  • Drug abuse
  • Cardiac Magnetic Resonance Imaging (cMRI) substudy: patients with renal failure are excluded from the cMRI study (MDRD <60)

Trial design

108 participants in 2 patient groups

Longitudinal study
Description:
Patients during overt and after cure of endogenous Cushing's syndrome.
Treatment:
Diagnostic Test: Cardiovascular status and quality of life
Cross-sectional study
Description:
Patients with proven endogenous Cushing's syndrome (overt or subclinical).
Treatment:
Diagnostic Test: Cardiovascular status and quality of life

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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