Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)

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

Detailed Description
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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.

Official Title
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Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)

Conditions
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Endogenous Cushing's Syndrome

Intervention / Treatment
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* Diagnostic Test: Cardiovascular status and quality of life


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Longitudinal study<br>Patients during overt and after cure of endogenous Cushing's syndrome. | Diagnostic Test: Cardiovascular status and quality of life<br>* 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<br>|
| Cross-sectional study<br>Patients with proven endogenous Cushing's syndrome (overt or subclinical). | Diagnostic Test: Cardiovascular status and quality of life<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular status - pathological cardiac MRI | Number of patients with pathological results (ejection fraction (<55%), pericardial effusion, thrombus, adipose tissue, perfusion defects, late enhancement, valvular or wall motion abnormalities). | 7 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular status - pathological cardiac echocardiography | 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. | 7 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endogenous Cushing's Syndrome, Cardiovascular status, Metabolic profile, Endothelial function, Quality of life