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Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome) (CV-CORT-EX)

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ClinicalTrials.gov Identifier: NCT03880513
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Endogenous Cushing's Syndrome Diagnostic Test: Cardiovascular status and quality of life

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 7 Years
Official Title: Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
Actual Study Start Date : October 2014
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021


Group/Cohort Intervention/treatment
Longitudinal study
Patients during overt and after cure of endogenous Cushing's syndrome.
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

Cross-sectional study
Patients with proven endogenous Cushing's syndrome (overt or subclinical).
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




Primary Outcome Measures :
  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 Outcome Measures :
  1. Cardiovascular status - pathological cardiac echocardiography [ Time Frame: 7 years ]
    Characterization of LV morphology and function, assessment of diastolic function and systolic strain. Assessment of regional and global LV function, characterization of right ventricular systolic function.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880513


Contacts
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Contact: Timo Deuschbein, MD +4993120139200 deutschbein_t@ukw.de
Contact: Stefanie Hahner, Professor +4993120139200 hahner_s@ukw.de

Locations
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Germany
University Hospital Wuerzburg Recruiting
Wuerzburg, Bavaria, Germany, 97080
Contact: Timo Deutschbein, MD    +4993120139200    deutschbein_T@ukw.de   
Sponsors and Collaborators
Wuerzburg University Hospital
Investigators
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Study Director: Martin Fassnacht, Professor University Hospital Wuerzburg

Additional Information:

Publications:
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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03880513     History of Changes
Other Study ID Numbers: CV-CORT-EX
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wuerzburg University Hospital:
Endogenous Cushing's Syndrome
Cardiovascular status
Metabolic profile
Endothelial function
Quality of life

Additional relevant MeSH terms:
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Syndrome
Cushing Syndrome
Disease
Pathologic Processes
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Hydrocortisone
Anti-Inflammatory Agents