Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia Clinical Trial

— cardiohcs  

Official title:

Evaluation of Cardiovascular Risk Profile in Adult Patients With Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency Diagnosed During Childhood

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01807364
• Other study ID #: AOR 10032
• Secondary ID: P091106
• Status: Completed
• Phase: N/A
• First received: November 16, 2012
• Last updated: June 16, 2016
• Start date: May 2011
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

Description:

Treatment with glucocorticoids and mineralocorticoids has changed congenital adrenal hyperplasia (CAH) from a fatal to a chronic lifelong disease. Long-term treatment, in particular the chronic (over-)treatment with glucocorticoids, may have an adverse effect on the cardiovascular risk profile in adult CAH patients. The objective of this study was to evaluate the cardiovascular risk profile of adult CAH patients.

DESIGN: Case control study Primary objective : detection of cardiovascular damage in patients with classical or non classical CAH diagnosed in childhood. The patients will be compared with age- and gender- and tobacco status- matched control.

Secondary objective Study of microvascular function Evaluation of cardiovascular risk factors Total cumulative (TCG) and total average (TAG) glucocorticoid doses will be calculated from pediatric and adult files and correlated to arterial macro- and microcirculatory dysfunction.

Primary outcome Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function Secondary outcome Peripheral and central blood pressure Skin capillary density and pulse-wave velocity Glucose and insulin during an oral glucose tolerance test Circulating cardiovascular risk markers (hsCRP, adiponectin, Interleukin-6) Lipid profile Anthropometry, fat and lean mass measured by dual-energy X-ray absorptiometry Total cumulative dose of glucocorticoid Number of subjects : 90 patients/90 controls Inclusion criteria of CAH patients

• Patients > 18 yrs with classical or non classical CAH diagnosed during childhood

• Absence of known cardiovascular disease

• Absence of combined oral contraceptives during the previous month Inclusion criteria of controls

• Age under 18

• Absence of known cardiovascular disease

• Absence of combined oral contraceptives during the previous month

Duration of the inclusion period: 3 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: April 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion criteria : patients

• Patients > 18 yrs with classical or non classical CAH diagnosed during childhood

• Absence of known cardiovascular disease

• Absence of combined oral contraceptives during the previous month

Inclusion criteria : controls

• Age > 18 yrs

• Absence of known cardiovascular disease

• Absence of combined oral contraceptives during the previous month

Exclusion criteria :

• Blood donation during the previous 3 months

• Cardiovascular disease

• Treatment by combined oral contraceptives

• Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Adrenal Hyperplasia, Congenital
• Adrenocortical Hyperfunction
• Adrenogenital Syndrome
• Congenital Adrenal Hyperplasia
• Hyperplasia

Locations

Country	Name	City	State
France	Pitié Salpêtrière Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound evaluation of intima-media thickness	Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function	day 1	No
Secondary	Blood pressure	Peripheral	day 1	No
Secondary	Skin capillary density		day 1	No
Secondary	Insulin during an oral glucose tolerance test		day 1	No
Secondary	Circulating cardiovascular risk markers	Interleukin-6	day 1	No
Secondary	Lipid profile		day 1	No
Secondary	Lean mass measured by dual-energy X-ray absorptiometry		day 1	No
Secondary	Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files	Calculated from pediatric and adult files	day 1	No
Secondary	Pulse-wave velocity		day 1	No
Secondary	Glucose during an oral glucose tolerance test		day 1	No
Secondary	Anthropometry measured by dual-energy X-ray absorptiometry		day 1	No
Secondary	Fat measured by dual-energy X-ray absorptiometry		day 1	No
Secondary	Blood pressure	Central	day 1	No
Secondary	Circulating cardiovascular risk markers	hsCRP	day 1	No
Secondary	Circulating cardiovascular risk markers	adiponectin	day 1	No