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

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