Abstract
BackgroundEndogenous 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).MethodA 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.DiscussionCV-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 registrationClinicalTrials.gov (https://clinicaltrials.gov/) NCT03880513, registration date: 19 March 2019 (retrospectively registered). Protocol Date: 28 March 2014, Version 2.
Highlights
Endogenous Cushing’s syndrome (CS) results in increased cardiovascular (CV) morbidity and mortality
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
Endogenous CS is associated with various CV risk factors leading to increased CV morbidity and mortality [2]
Summary
Endogenous Cushing’s syndrome (CS) results in increased cardiovascular (CV) morbidity and mortality. Irrespective of the underlying aetiology, CS patients usually present with a typical clinical phenotype (including facial plethora, proximal myopathy, purple striae, and easy bruising) and suffer from various comorbidities, including relevant cardiovascular (CV) risk factors like arterial hypertension, diabetes mellitus, and dyslipidaemia [3, 4] The latter are likely to contribute to increased CV morbidity in CS patients, as outlined by prevalences of more than 40% for myocardial hypertrophy [5, 6], up to 30% for arteriosclerosis [7,8,9], and up to 5% for congestive heart failure [10, 11]. Patients mainly died of CV disease, which is probably explained by their higher incidence of myocardial infarction and ischaemic stroke compared to the general population [1, 12,13,14,15,16]
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