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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2022-10-31

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.

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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.

Conditions

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Endogenous Cushing's Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Longitudinal study

Patients during overt and after cure of endogenous Cushing's syndrome.

Cardiovascular status and quality of life

Intervention Type 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

Cross-sectional study

Patients with proven endogenous Cushing's syndrome (overt or subclinical).

Cardiovascular status and quality of life

Intervention Type 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

Interventions

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Cardiovascular 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

Intervention Type DIAGNOSTIC_TEST

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No