Cardiovascular Status in Patients With Chronic Cortisol Deficiency (Adrenal Insufficiency)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Cardiovascular status - mean diastolic blood pressure
研究概览
简要总结
Within this trial, the cardiovascular status and metabolic profile of patients with chronic primary adrenal insufficiency is evaluated.
详细描述
An unfavorable metabolic profile in patients with adrenal insufficiency (AI) under hormone replacement therapy with hydrocortisone (HC) has been revealed in one recent analysis. Furthermore an increased cardiovascular (CV) morbidity in AI is assumed. The aim of the study is to evaluate the metabolic profile and cardiovascular status in patients with primary AI. Patients with primary AI under standard replacement therapy with HC undergo detailed CV evaluation (including e.g. laboratory test, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Chronic primary adrenal insufficiency
- •Adequate hormone replacement therapy (>3 years)
- •Age >18 years
- •Patient's informed consent
排除标准
- •Hormone replacement therapy with an other glucocorticoid than hydrocortisone
- •Pharmacotherapy with glucocorticoids
- •Congenital adrenal hyperplasia
- •Coronary heart disease
- •Heart failure
- •Systemic disease with (potential) cardiac involvement (e.g. amyloidosis, lung fibrosis)
- •Pregnancy
- •Chronic alcohol abuse
- •Malignant disease
- •Arterial hypertension
- •Chronic renal failure (MDRD <60)
结局指标
主要结局
Cardiovascular status - mean diastolic blood pressure
时间窗: 12 months
Measurement of the diastolic resting blood pressure (in mmHg). Analysis of the mean diastolic blood pressure (of all participating patients).
Cardiovascular status - mean BMI
时间窗: 12 months
Measurement of weight (in kg) and height (qm); weight and height will be combined to report the Body Mass Index/BMI (kg/qm). Analysis of the mean BMI (of all participating patients) and the number of patients with increased BMI (\>25 kg/qm).
Cardiovascular status - mean systolic blood pressure (24h blood pressure measurement)
时间窗: 12 months
Measurement of the mean systolic blood pressure (in mmHg) by 24h blood pressure profiles. Analysis of the mean systolic blood pressure (of all participating patients) and the number of patients with an increased mean systolic blood pressure (\>140 mmHg).
Cardiovascular status - mean systolic blood pressure
时间窗: 12 months
Measurement of the systolic resting blood pressure (in mmHg). Analysis of the mean systolic blood pressure (of all participating patients) and the number of patients with increased systolic blood pressure (\>140 mmHg).
Cardiovascular status - anamnesis
时间窗: 12 months
Evaluation of the cardiovascular status of patients with chronic adrenal insufficiency by anamnesis/documentation of cardiovascular risk factors. Prevalence of cardiovascular risk factors (diabetes, hypertension, hyperlipidemia, obesity) in participating patients.
Cardiovascular status - mean HbA1c
时间窗: 12 months
Measurement of HbA1c-values (in %). Analysis of the mean HbA1c-value and the number of patients with increased HbA1c (\>6.5%).
Cardiovascular status - mean triglyceride-level
时间窗: 12 months
Measurement of triglyceride-levels (in mg/dl). Analysis of the mean triglyceride-level and the number of patients with increased triglyceride-levels (\>200mg/dl).
Cardiovascular status - mean ejection fraction
时间窗: 12 months
Analysis of the mean ejection fraction (in %) (by echocardiography of all participating patients) and the number of patients with a pathologic ejection fraction (\<55%).
Cardiovascular status - mean cholesterol-level
时间窗: 12 months
Measurement of cholesterol-levels (in mg/dl). Analysis of the mean cholesterol-level and the number of patients with increased cholesterol-levels (\>200mg/dl).
Cardiovascular status - reactive hyperaemia index
时间窗: 12 months
Evaluation of the reactive hyperaemia index (endothelial function). Analysis of the number of patients with a pathological reactive hyperaemia index (pathological results ≤ 1.67).
Cardiovascular status - pathological cardiac MRI
时间窗: 12 months
Number of patients with pathological results (ejection fraction (\<55%), pericardial effusion, thrombus, adipose tissue, perfusion defects, late enhancement, valvular or wall motion abnormalities).
Cardiovascular status - non-dipper-profiles
时间窗: 12 months
Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement.
Cardiovascular status - diastolic function
时间窗: 12 months
Measurement of the diastolic function by echocardiography. Analysis of the number of patients with a pathological diastolic function (E/A ratio; values \<1 were rated as pathological).
次要结局
未报告次要终点