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

Wuerzburg University Hospital108 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Endogenous Cushing's Syndrome

Interventions

Cardiovascular status and quality of lifeDIAGNOSTIC_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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University Hospital Wuerzburg

Würzburg, Bavaria, Germany

Outcomes

Primary Outcomes

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).

Time frame: 7 years

Secondary Outcomes

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.

Time frame: 7 years

Data from ClinicalTrials.gov

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