cardiohcs: Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT01807364

Collaborator

(none)

170

Enrollment

Location

Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Adrenal Hyperplasia

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Congenital adrenal hyperplasia Patients > 18 yrs with classical or non classical CAH diagnosed during childhood
controls control patients

Outcome Measures

Primary Outcome Measures

Ultrasound evaluation of intima-media thickness [day 1]
Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function

Secondary Outcome Measures

Blood pressure [day 1]
Peripheral
Skin capillary density [day 1]
Insulin during an oral glucose tolerance test [day 1]
Circulating cardiovascular risk markers [day 1]
Interleukin-6
Lipid profile [day 1]
Lean mass measured by dual-energy X-ray absorptiometry [day 1]
Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files [day 1]
Calculated from pediatric and adult files
Pulse-wave velocity [day 1]
Glucose during an oral glucose tolerance test [day 1]
Anthropometry measured by dual-energy X-ray absorptiometry [day 1]
Fat measured by dual-energy X-ray absorptiometry [day 1]
Blood pressure [day 1]
Central
Circulating cardiovascular risk markers [day 1]
hsCRP
Circulating cardiovascular risk markers [day 1]
adiponectin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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