Cardiovascular Status in Adrenal Insufficiency

Study Overview
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Brief Summary
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Within this trial, the cardiovascular status and metabolic profile of patients with chronic primary adrenal insufficiency is evaluated.

Detailed Description
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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).

Official Title
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Cardiovascular Status in Patients With Chronic Cortisol Deficiency (Adrenal Insufficiency)

Conditions
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Adrenal Insufficiency

Intervention / Treatment
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* Diagnostic Test: Cardiovascular evaluation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic primary adrenal insufficiency Adequate hormone replacement therapy (>3 years) Age >18 years Patient's informed consent Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary adrenal insufficiency<br>Patients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone. | Diagnostic Test: Cardiovascular evaluation<br>* Cardiovascular evaluation includes anamnesis, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular status - anamnesis | 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. | 12 months | 
| Cardiovascular status - mean systolic blood pressure | 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). | 12 months | 
| Cardiovascular status - mean diastolic blood pressure | Measurement of the diastolic resting blood pressure (in mmHg). Analysis of the mean diastolic blood pressure (of all participating patients). | 12 months | 
| Cardiovascular status - mean BMI | 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). | 12 months | 
| Cardiovascular status - mean HbA1c | Measurement of HbA1c-values (in %). Analysis of the mean HbA1c-value and the number of patients with increased HbA1c (>6.5%). | 12 months | 
| Cardiovascular status - mean cholesterol-level | Measurement of cholesterol-levels (in mg/dl). Analysis of the mean cholesterol-level and the number of patients with increased cholesterol-levels (>200mg/dl). | 12 months | 
| Cardiovascular status - mean triglyceride-level | Measurement of triglyceride-levels (in mg/dl). Analysis of the mean triglyceride-level and the number of patients with increased triglyceride-levels (>200mg/dl). | 12 months | 
| Cardiovascular status - reactive hyperaemia index | Evaluation of the reactive hyperaemia index (endothelial function). Analysis of the number of patients with a pathological reactive hyperaemia index (pathological results ≤ 1.67). | 12 months | 
| Cardiovascular status - mean systolic blood pressure (24h blood pressure measurement) | 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). | 12 months | 
| Cardiovascular status - non-dipper-profiles | Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement. | 12 months | 
| Cardiovascular status - mean ejection fraction | Analysis of the mean ejection fraction (in %) (by echocardiography of all participating patients) and the number of patients with a pathologic ejection fraction (<55%). | 12 months | 
| Cardiovascular status - diastolic function | 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). | 12 months | 
| Cardiovascular status - pathological cardiac MRI | Number of patients with pathological results (ejection fraction (<55%), pericardial effusion, thrombus, adipose tissue, perfusion defects, late enhancement, valvular or wall motion abnormalities). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary adrenal insufficiency, Cardiovascular status, Metabolic profile