Endogenous Cushing's SyndromeCV-CORT-EXNCT03880513
Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
An observational study of Endogenous Cushing's Syndrome, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
Within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endogenous Cushing's Syndrome
- What is being tested?
- Cardiovascular status and quality of life
- How many people
- 108 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2014to Oct 2022
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated.
Read the 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.
- Conditions
- Endogenous Cushing's Syndrome
- Being tested
- Cardiovascular status and quality of life
- Keywords
- Endogenous Cushing's Syndrome, Cardiovascular status, Metabolic profile, Endothelial function, Quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Longitudinal study | Patients during overt and after cure of endogenous Cushing's syndrome. Receives: Diagnostic Test: Cardiovascular status and quality of life | |
| Cross-sectional study | Patients with proven endogenous Cushing's syndrome (overt or subclinical). Receives: Diagnostic Test: Cardiovascular status and quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 years
Secondary outcomes (1)
Cardiovascular status - pathological cardiac echocardiography
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.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study startOct 2014
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endogenous Cushing's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 108 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Fassnacht, Professor, Study director, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880513
- Sponsor's protocol ID
- CV-CORT-EX
- Acronym
- CV-CORT-EX
- Status last verified
- Apr 2023
- First submitted
- 12 Jul 2018
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25093618Ehrlich 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.
PubMed 33419423
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
- ClinicalTrials.gov ID
- NCT03880513
- Acronym / sponsor ID
- CV-CORT-EX / CV-CORT-EX
- Conditions
- Endogenous Cushing's Syndrome
- Keywords
- Endogenous Cushing's Syndrome, Cardiovascular status, Metabolic profile, Endothelial function, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Longitudinal study | – | Diagnostic Test: Cardiovascular status and quality of lifePatients during overt and after cure of endogenous Cushing's syndrome. |
| Cross-sectional study | – | Diagnostic Test: Cardiovascular status and quality of lifePatients with proven endogenous Cushing's syndrome (overt or subclinical). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular status and quality of lifePsychosocial 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 | Diagnostic test | Cross-sectional study, Longitudinal study |
Primary outcome
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).
1 secondary outcome
Cardiovascular status - pathological cardiac echocardiography
Time frame: 7 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 25093618Kamenicky 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.
- Derived from this study: PubMed 33419423Ehrlich 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Fassnacht, Professor study director
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endogenous Cushing's Syndrome, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular status - pathological cardiac MRI (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880513, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.