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

April 27, 2023 updated by: Wuerzburg University Hospital
Within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Wuerzburg, Bavaria, Germany, 97080
        • University Hospital Wuerzburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

October 1, 2022

Study Completion (Actual)

October 1, 2022

Study Registration Dates

First Submitted

July 12, 2018

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 19, 2019

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 27, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV-CORT-EX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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