Clinical trial NCT03880513: Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
Official title: Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endogenous Cushing's Syndrome
Keywords: Endogenous Cushing's Syndrome
Cardiovascular status
Metabolic profile
Endothelial function
Quality of life
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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)

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiovascular status - pathological cardiac MRI
timeFrame: 7 years
Secondary outcomes:
measure: Cardiovascular status - pathological cardiac echocardiography
timeFrame: 7 years
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
state: Bavaria
Study officials:
affiliation: University Hospital Wuerzburg
name: Martin Fassnacht, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.