Cardiovascular Status in Patients With Endogenous Cortisol Excess (Cushing's Syndrome)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Cardiovascular status - pathological cardiac MRI
研究概览
简要总结
Within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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)
结局指标
主要结局
Cardiovascular status - pathological cardiac MRI
时间窗: 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).
次要结局
- Cardiovascular status - pathological cardiac echocardiography(7 years)