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

Endogenous Cushing's Syndrome Clinical Trial

— CV-CORT-EX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03880513
• Other study ID #: CV-CORT-EX
• Status: Completed
• Start date: October 2014
• Est. completion date: October 2022

Study information

• Verified date: April 2023
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: October 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cushing Syndrome
• Endogenous Cushing's Syndrome
• Syndrome

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
Germany	University Hospital Wuerzburg	Wuerzburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Wuerzburg University Hospital

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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