NCT03880513

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 19, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

8 years

First QC Date

July 12, 2018

Last Update Submit

April 27, 2023

Conditions

Endogenous Cushing's Syndrome

Keywords

Endogenous Cushing's SyndromeCardiovascular statusMetabolic profileEndothelial functionQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Cardiovascular status - pathological cardiac echocardiography

    7 years

Study Arms (2)

Longitudinal study

Patients during overt and after cure of endogenous Cushing's syndrome.

Diagnostic Test: Cardiovascular status and quality of life

Cross-sectional study

Patients with proven endogenous Cushing's syndrome (overt or subclinical).

Diagnostic Test: Cardiovascular status and quality of life

Interventions

Cardiovascular status and quality of lifeDIAGNOSTIC_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

Cross-sectional studyLongitudinal study

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (2)

  • 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.

    PMID: 25093618BACKGROUND

  • 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.

    PMID: 33419423DERIVED

Study Officials

  • Martin Fassnacht, Professor

    University Hospital Wuerzburg

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
7 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2018

First Posted

March 19, 2019

Study Start

October 1, 2014

Primary Completion

October 1, 2022

Study Completion

October 1, 2022

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

DE(1)