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Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01807364
Acronym
cardiohcs
Enrollment
170
Registered
2013-03-08
Start date
2011-05-31
Completion date
2016-04-30
Last updated
2016-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Adrenal Hyperplasia

Keywords

Congenital adrenal hyperplasia (CAH), Cardiovascular risk, Microvascular dysfunction

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.

Detailed 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

Interventions

None listed

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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 * 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

Design outcomes

Primary

MeasureTime frameDescription
Ultrasound evaluation of intima-media thicknessday 1Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function

Secondary

MeasureTime frameDescription
Skin capillary densityday 1
Insulin during an oral glucose tolerance testday 1
Circulating cardiovascular risk markersday 1Interleukin-6
Lipid profileday 1
Lean mass measured by dual-energy X-ray absorptiometryday 1
Blood pressureday 1Peripheral
Pulse-wave velocityday 1
Glucose during an oral glucose tolerance testday 1
Anthropometry measured by dual-energy X-ray absorptiometryday 1
Fat measured by dual-energy X-ray absorptiometryday 1
Total cumulative dose of glucocorticoid will be calculated from pediatric and adult filesday 1Calculated from pediatric and adult files

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026