Kristina Ehrlich1, Caroline Morbach2,3,4, Theresa Reiter2, Peter Ulrich Heuschmann5,6, Anke Hannemann7,8, Martin Fassnacht1,3, Stefan Störk2,3, Stefanie Hahner1, Timo Deutschbein9,10. 1. Department of Internal Medicine I, Division of Endocrinology and Diabetes, University Hospital Würzburg, University of Würzburg, Oberdürrbacher Straße 6, 97080, Würzburg, Germany. 2. Department of Internal Medicine I, Division of Cardiology, University Hospital Würzburg, University of Würzburg, Würzburg, Germany. 3. Comprehensive Heart Failure Centre, University and University Hospital Würzburg, University of Würzburg, Würzburg, Germany. 4. Academic Core Lab Ultrasound-based Cardiovascular Imaging, University Hospital Würzburg, University of Würzburg, Würzburg, Germany. 5. Clinical Trial Centre, University Hospital Würzburg, University of Würzburg, Würzburg, Germany. 6. Institute of Clinical Epidemiology and Biometry, University of Würzburg, Würzburg, Germany. 7. Institute of Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Greifswald, Germany. 8. German Centre for Cardiovascular Research DZHK, Partner Site Greifswald, University Medicine Greifswald, Greifswald, Germany. 9. Department of Internal Medicine I, Division of Endocrinology and Diabetes, University Hospital Würzburg, University of Würzburg, Oberdürrbacher Straße 6, 97080, Würzburg, Germany. deutschbein_t@ukw.de. 10. Medicover Oldenburg MVZ, Oldenburg, Germany. deutschbein_t@ukw.de.
Abstract
BACKGROUND: Endogenous Cushing's syndrome (CS) results in increased cardiovascular (CV) morbidity and mortality. So far, most studies focussed on distinct disease entities rather than the integrity of the CV system. We here describe the design of the Cardiovascular Status in Endogenous Cortisol Excess Study (CV-CORT-EX), a study aiming to comprehensively investigate the health status of patients with endogenous CS (with a particular focus on CV phenotypes, biochemical aspects, quality of life, and psychosocial status). METHOD: A prospective non-interventional cohort study performed at a German tertiary referral centre. At the time of enrolment, patients will be categorised as: (1) newly diagnosed overt CS, (2) recurrent overt CS, (3) CS in remission, (4) presence of mild autonomous cortisol excess (MACE). The target cohorts will be n = 40 (groups 1 + 2), n = 80 (group 3), and n = 20 (group 4). Patients with overt CS at the time of enrolment will be followed for 12 months after remission (with re-evaluations after 6 and 12 months). At each visit, patients will undergo transthoracic echocardiography, cardiac magnetic resonance imaging, 24-h electrocardiogram, 24-h blood pressure measurement, and indirect evaluation of endothelial function. Furthermore, a standardised clinical investigation, an extensive biochemical workup, and a detailed assessment of quality of life and psychosocial status will be applied. Study results (e.g. cardiac morphology and function according to transthoracic echocardiography and cardiac magnetic resonance imaging; e.g. prevalence of CV risk factors) from patients with CS will be compared with matched controls without CS derived from two German population-based studies. DISCUSSION: CV-CORT-EX is designed to provide a comprehensive overview of the health status of patients with endogenous CS, mainly focussing on CV aspects, and the holistic changes following remission. TRAIL REGISTRATION: ClinicalTrials.gov ( https://clinicaltrials.gov/ ) NCT03880513, registration date: 19 March 2019 (retrospectively registered). Protocol Date: 28 March 2014, Version 2.
BACKGROUND: Endogenous Cushing's syndrome (CS) results in increased cardiovascular (CV) morbidity and mortality. So far, most studies focussed on distinct disease entities rather than the integrity of the CV system. We here describe the design of the Cardiovascular Status in Endogenous Cortisol Excess Study (CV-CORT-EX), a study aiming to comprehensively investigate the health status of patients with endogenous CS (with a particular focus on CV phenotypes, biochemical aspects, quality of life, and psychosocial status). METHOD: A prospective non-interventional cohort study performed at a German tertiary referral centre. At the time of enrolment, patients will be categorised as: (1) newly diagnosed overt CS, (2) recurrent overt CS, (3) CS in remission, (4) presence of mild autonomous cortisol excess (MACE). The target cohorts will be n = 40 (groups 1 + 2), n = 80 (group 3), and n = 20 (group 4). Patients with overt CS at the time of enrolment will be followed for 12 months after remission (with re-evaluations after 6 and 12 months). At each visit, patients will undergo transthoracic echocardiography, cardiac magnetic resonance imaging, 24-h electrocardiogram, 24-h blood pressure measurement, and indirect evaluation of endothelial function. Furthermore, a standardised clinical investigation, an extensive biochemical workup, and a detailed assessment of quality of life and psychosocial status will be applied. Study results (e.g. cardiac morphology and function according to transthoracic echocardiography and cardiac magnetic resonance imaging; e.g. prevalence of CV risk factors) from patients with CS will be compared with matched controls without CS derived from two German population-based studies. DISCUSSION: CV-CORT-EX is designed to provide a comprehensive overview of the health status of patients with endogenous CS, mainly focussing on CV aspects, and the holistic changes following remission. TRAIL REGISTRATION: ClinicalTrials.gov ( https://clinicaltrials.gov/ ) NCT03880513, registration date: 19 March 2019 (retrospectively registered). Protocol Date: 28 March 2014, Version 2.
Entities:
Keywords:
Cardiac magnetic resonance imaging; Cardiovascular status; Cushing’s syndrome; Echocardiography; Endogenous; Glucocorticoid excess; Hormones; Left ventricular hypertrophy; Metabolic profile; Quality of life
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