Endogenous Cushing's Syndrome
Conditions
Keywords
Endogenous Cushing's Syndrome, Cardiovascular status, Metabolic profile, Endothelial function, Quality of life
Brief summary
Within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated.
Detailed 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.
Interventions
DIAGNOSTIC_TESTCardiovascular status and quality of life
Psychosocial and cardiovascular evaluation includes medical history, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, transthoracic echocardiography, cardiac MRI, and quality of life assessment
Sponsors
Wuerzburg University Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular status - pathological cardiac MRI | 7 years | Number of patients with pathological results (ejection fraction (\<55%), pericardial effusion, thrombus, adipose tissue, perfusion defects, late enhancement, valvular or wall motion abnormalities). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiovascular status - pathological cardiac echocardiography | 7 years | Characterization of left ventricular (LV) morphology and function, assessment of diastolic function and systolic strain. Assessment of regional and global LV function, characterization of right ventricular systolic function. |
Countries
Germany
Outcome results
None listed