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Completed

NCT Number: NCT03880513

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cardiovascular status and quality of life

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

Primary outcomes

  1. Cardiovascular status - pathological cardiac MRI

    Time frame: 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 outcomes

  1. Cardiovascular status - pathological cardiac echocardiography

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Acronym: CV-CORT-EX

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2019
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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