Clinical trial NCT03426319: Cardiovascular Status in Adrenal Insufficiency
Official title: Cardiovascular Status in Patients With Chronic Cortisol Deficiency (Adrenal Insufficiency)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Insufficiency
Keywords: Primary adrenal insufficiency
Cardiovascular status
Metabolic profile
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2018-02-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic primary adrenal insufficiency

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).

Eligibility 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)

Primary outcomes:
measure: Cardiovascular status - anamnesis
timeFrame: 12 months
measure: Cardiovascular status - mean systolic blood pressure
timeFrame: 12 months
measure: Cardiovascular status - mean diastolic blood pressure
timeFrame: 12 months
measure: Cardiovascular status - mean BMI
timeFrame: 12 months
measure: Cardiovascular status - mean HbA1c
timeFrame: 12 months
measure: Cardiovascular status - mean cholesterol-level
timeFrame: 12 months
measure: Cardiovascular status - mean triglyceride-level
timeFrame: 12 months
measure: Cardiovascular status - reactive hyperaemia index
timeFrame: 12 months
measure: Cardiovascular status - mean systolic blood pressure (24h blood pressure measurement)
timeFrame: 12 months
measure: Cardiovascular status - non-dipper-profiles
timeFrame: 12 months
measure: Cardiovascular status - mean ejection fraction
timeFrame: 12 months
measure: Cardiovascular status - diastolic function
timeFrame: 12 months
measure: Cardiovascular status - pathological cardiac MRI
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University Hospital Wuerzburg
Study officials:
References:
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citation: 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.
citation: 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.
citation: 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.