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Table 2 Primary and secondary study objectives

From: Rationale and design of the cardiovascular status in patients with endogenous cortisol excess study (CV-CORT-EX): a prospective non-interventional follow-up study

Primary study objectives:
• Prevalence and magnitude of LV hypertrophy (transthoracic echocardiography)
• Description of LV deformation characteristics (transthoracic echocardiography)
• Quantification of LV, total heart mass, and ventricular volumes (cardiac MRI)
• Assessment of systolic function and myocardial structural fibrosis (cardiac MRI)
Secondary study objectives:
• Cardiac morphology and function (using transthoracic echocardiography and cardiac MRI)
• Endothelial function (using Endo-PAT2000)
• Blood pressure (using resting and 24-h blood pressure measurement)
• Heart rate variability profile (using resting and 24-h electrocardiogram)
• Clinical features (waist-to-hip ratio, body mass index, bio-impedance analysis)
• Muscle strength (chair rising test, hand grip strength)
• Biochemistry (including hormonal, metabolic, cardiac and routine parameters)
• Evaluation of QoL and psychosocial status (using six questionnaires):
 - Disease-specific QoL (CushingQoL, Tuebingen CD-25)
 - Generic QoL (SF-36)
 - Generic health status (EQ-5D-3L)
 - Anxiety (GAD-7)
 - Depressive and panic disorders (brief PHQ-D)
• Comparison between patients with CS and controls without CS (i.e. from STAAB and SHIP-Trend)
• Comparison between patients with overt CS and patients with CS in remission
  1. Abbreviations: CS Cushing’s syndrome, LV left ventricular; MRI magnetic resonance imaging, QoL quality of life, SHIP-Trend Study of Health in Pomerania-Trend, STAAB Characteristics and Course of Heart Failure Stages A-B and Determinants of Progression