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Within this trial, the cardiovascular status and metabolic profile of patients with chronic primary adrenal insufficiency is evaluated.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary adrenal insufficiency | Patients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiovascular evaluation | Diagnostic Test | Cardiovascular evaluation includes anamnesis, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI. |
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic primary adrenal insufficiency
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Wuerzburg | Würzburg | 97080 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16968806 | Background | Bergthorsdottir R, Leonsson-Zachrisson M, Oden A, Johannsson G. Premature mortality in patients with Addison's disease: a population-based study. J Clin Endocrinol Metab. 2006 Dec;91(12):4849-53. doi: 10.1210/jc.2006-0076. Epub 2006 Sep 12. | |
| 19858318 | Background | Erichsen MM, Lovas K, Skinningsrud B, Wolff AB, Undlien DE, Svartberg J, Fougner KJ, Berg TJ, Bollerslev J, Mella B, Carlson JA, Erlich H, Husebye ES. Clinical, immunological, and genetic features of autoimmune primary adrenal insufficiency: observations from a Norwegian registry. J Clin Endocrinol Metab. 2009 Dec;94(12):4882-90. doi: 10.1210/jc.2009-1368. Epub 2009 Oct 26. |
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| ID | Term |
|---|---|
| D000309 | Adrenal Insufficiency |
| D000224 | Addison Disease |
| ID | Term |
|---|---|
| D000307 | Adrenal Gland Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| 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 |
| 19684055 | Background | Filipsson H, Johannsson G. GH replacement in adults: interactions with other pituitary hormone deficiencies and replacement therapies. Eur J Endocrinol. 2009 Nov;161 Suppl 1:S85-95. doi: 10.1530/EJE-09-0319. Epub 2009 Aug 14. |
| 22112807 | Background | Johannsson G, Nilsson AG, Bergthorsdottir R, Burman P, Dahlqvist P, Ekman B, Engstrom BE, Olsson T, Ragnarsson O, Ryberg M, Wahlberg J, Biller BM, Monson JP, Stewart PM, Lennernas H, Skrtic S. Improved cortisol exposure-time profile and outcome in patients with adrenal insufficiency: a prospective randomized trial of a novel hydrocortisone dual-release formulation. J Clin Endocrinol Metab. 2012 Feb;97(2):473-81. doi: 10.1210/jc.2011-1926. Epub 2011 Nov 23. |
| 27211797 | Background | Burger-Stritt S, Pulzer A, Hahner S. Quality of Life and Life Expectancy in Patients with Adrenal Insufficiency: What Is True and What Is Urban Myth? Front Horm Res. 2016;46:171-83. doi: 10.1159/000443918. Epub 2016 May 17. |
| 27623069 | Background | Stewart PM, Biller BM, Marelli C, Gunnarsson C, Ryan MP, Johannsson G. Exploring Inpatient Hospitalizations and Morbidity in Patients With Adrenal Insufficiency. J Clin Endocrinol Metab. 2016 Dec;101(12):4843-4850. doi: 10.1210/jc.2016-2221. Epub 2016 Sep 13. |