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

Completed

• Conditions: Endogenous Cushing's Syndrome
• Interventions: Diagnostic Test: Cardiovascular status and quality of life

• Registration Number: NCT03880513
• Lead Sponsor: Wuerzburg University Hospital

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2018-07-12
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-19
• Primary Completion: 2022-10
• Study Completion: 2022-10
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cross-sectional study	Cardiovascular status and quality of life	Patients with proven endogenous Cushing's syndrome (overt or subclinical).
Longitudinal study	Cardiovascular status and quality of life	Patients during overt and after cure of endogenous Cushing's syndrome.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Bavaria, Germany