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Cardiovascular Status in Adrenal Insufficiency (CVCORT-AI)

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ClinicalTrials.gov Identifier: NCT03426319
Recruitment Status : Completed
First Posted : February 8, 2018
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Wuerzburg University Hospital

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

Condition or disease Intervention/treatment
Adrenal Insufficiency Diagnostic Test: Cardiovascular evaluation

Detailed Description:
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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Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Cardiovascular Status in Patients With Chronic Cortisol Deficiency (Adrenal Insufficiency)
Actual Study Start Date : August 2013
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014


Group/Cohort Intervention/treatment
Primary adrenal insufficiency
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.




Primary Outcome Measures :
  1. Cardiovascular status - anamnesis [ Time Frame: 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.

  2. Cardiovascular status - mean systolic blood pressure [ Time Frame: 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).

  3. Cardiovascular status - mean diastolic blood pressure [ Time Frame: 12 months ]
    Measurement of the diastolic resting blood pressure (in mmHg). Analysis of the mean diastolic blood pressure (of all participating patients).

  4. Cardiovascular status - mean BMI [ Time Frame: 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).


  5. Cardiovascular status - mean HbA1c [ Time Frame: 12 months ]
    Measurement of HbA1c-values (in %). Analysis of the mean HbA1c-value and the number of patients with increased HbA1c (>6.5%).

  6. Cardiovascular status - mean cholesterol-level [ Time Frame: 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).

  7. Cardiovascular status - mean triglyceride-level [ Time Frame: 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).

  8. Cardiovascular status - reactive hyperaemia index [ Time Frame: 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).

  9. Cardiovascular status - mean systolic blood pressure (24h blood pressure measurement) [ Time Frame: 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).

  10. Cardiovascular status - non-dipper-profiles [ Time Frame: 12 months ]
    Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement.

  11. Cardiovascular status - mean ejection fraction [ Time Frame: 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%).

  12. Cardiovascular status - diastolic function [ Time Frame: 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).

  13. Cardiovascular status - pathological cardiac MRI [ Time Frame: 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic primary adrenal insufficiency
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03426319


Locations
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Germany
University Hospital Wuerzburg
Wuerzburg, Germany, 97080
Sponsors and Collaborators
Wuerzburg University Hospital

Publications:

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Responsible Party: Wuerzburg University Hospital
ClinicalTrials.gov Identifier: NCT03426319     History of Changes
Other Study ID Numbers: CV-CORT-AI
First Posted: February 8, 2018    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wuerzburg University Hospital:
Primary adrenal insufficiency
Cardiovascular status
Metabolic profile
Additional relevant MeSH terms:
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Adrenal Insufficiency
Adrenal Gland Diseases
Endocrine System Diseases
Epinephrine
Racepinephrine
Epinephryl borate
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents