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Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia (cardiohcs)

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Congenital Adrenal Hyperplasia

Study type

Observational

Funder types

Other

Identifiers

NCT01807364
P091106 (Other Identifier)
AOR 10032

Details and patient eligibility

About

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.

Full 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

Enrollment

170 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

170 participants in 2 patient groups

Congenital adrenal hyperplasia
Description:
Patients \> 18 yrs with classical or non classical CAH diagnosed during childhood
controls
Description:
control patients

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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