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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