An observational study in Adrenal Insufficiency, sponsored by Wuerzburg University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Wuerzburg University Hospital · Observational
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).
136 studies on the registry are indexed under Adrenal Insufficiency; 27 are open to participants now.
This study's enrollment of 68 is below the median of 85 across 59 observational studies indexed under Adrenal Insufficiency.
Browse Adrenal Insufficiency studies →Wuerzburg University Hospital is the lead sponsor of 98 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with chronic primary adrenal insufficiency
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone.
Diagnostic Test: Cardiovascular evaluation
Cardiovascular evaluation includes anamnesis, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI.
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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%).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Cardiovascular status - non-dipper-profiles
Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement.
Time frame: 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%).
Time frame: 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).
Time frame: 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).
Time frame: 12 months
Plan to share: Undecided
Ran from Aug 2013 to primary completion in Jun 2014, 10 months.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Wuerzburg University Hospital