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Completed

NCT Number: NCT03426319

Cardiovascular Status in Adrenal Insufficiency

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

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Key information

Conditions

Adrenal Insufficiency Addison Disease Adrenal Gland Diseases Autoimmune Diseases Endocrine System Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Wuerzburg

Würzburg, 97080, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Wuerzburg University Hospital

Other

Registry information

Official study title

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

Acronym: CVCORT-AI

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2018
Registry last updated
Feb 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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