Cardiovascular Status in Adrenal Insufficiency

Completed

• Conditions: Adrenal Insufficiency
• Interventions: Diagnostic Test: Cardiovascular evaluation

• Registration Number: NCT03426319
• Lead Sponsor: Wuerzburg University Hospital

Brief Summary

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

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).

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2018-01
• Study First Submitted: 2018-01-08
• Study First Submitted QC: 2018-02-01
• Last Update Submitted: 2018-02-01
• Study First Posted: 2018-02-08
• Last Update Posted: 2018-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary adrenal insufficiency	Cardiovascular evaluation	Patients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone.

Primary Outcome Measures

Name	Time	Method
Cardiovascular status - mean triglyceride-level	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).
Cardiovascular status - mean diastolic blood pressure	12 months	Measurement of the diastolic resting blood pressure (in mmHg). Analysis of the mean diastolic blood pressure (of all participating patients).
Cardiovascular status - mean BMI	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).
Cardiovascular status - mean systolic blood pressure (24h blood pressure measurement)	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).
Cardiovascular status - anamnesis	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.
Cardiovascular status - mean HbA1c	12 months	Measurement of HbA1c-values (in %). Analysis of the mean HbA1c-value and the number of patients with increased HbA1c (\>6.5%).
Cardiovascular status - mean ejection fraction	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%).
Cardiovascular status - mean systolic blood pressure	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).
Cardiovascular status - mean cholesterol-level	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).
Cardiovascular status - reactive hyperaemia index	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).
Cardiovascular status - pathological cardiac MRI	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).
Cardiovascular status - non-dipper-profiles	12 months	Documentation of the number of patients with a non-dipper-profile during a 24h blood pressure measurement.
Cardiovascular status - diastolic function	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).

Trial Locations

Locations (1)

University Hospital Wuerzburg; 🇩🇪 Wuerzburg, Germany