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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Longitudinal study | Patients during overt and after cure of endogenous Cushing's syndrome. |
| |
| Cross-sectional study | Patients with proven endogenous Cushing's syndrome (overt or subclinical). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular status and quality of life | Diagnostic Test | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| Martin Fassnacht, Professor | Wuerzburg University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Wuerzburg | Würzburg | Bavaria | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25093618 | Background | Kamenicky P, Redheuil A, Roux C, Salenave S, Kachenoura N, Raissouni Z, Macron L, Guignat L, Jublanc C, Azarine A, Brailly S, Young J, Mousseaux E, Chanson P. Cardiac structure and function in Cushing's syndrome: a cardiac magnetic resonance imaging study. J Clin Endocrinol Metab. 2014 Nov;99(11):E2144-53. doi: 10.1210/jc.2014-1783. Epub 2014 Aug 5. | |
| 33419423 |
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| Ehrlich K, Morbach C, Reiter T, Heuschmann PU, Hannemann A, Fassnacht M, Stork S, Hahner S, Deutschbein T. Rationale and design of the cardiovascular status in patients with endogenous cortisol excess study (CV-CORT-EX): a prospective non-interventional follow-up study. BMC Endocr Disord. 2021 Jan 8;21(1):11. doi: 10.1186/s12902-020-00665-7. |