Cardiovascular Status in Adrenal Insufficiency (CVCORT-AI)

Wuerzburg University Hospital

Status: Completed

Conditions: Adrenal Insufficiency

Treatments: Diagnostic Test: Cardiovascular evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT03426319

CV-CORT-AI

Details and patient eligibility

About

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

Full 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).

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

68 participants in 1 patient group

Primary adrenal insufficiency

Description:

Patients with primary adrenal insufficiency on hormone replacement therapy with hydrocortisone.

Treatment:

Diagnostic Test: Cardiovascular evaluation