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

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Adrenal Hyperplasia

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

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpétrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Congenital adrenal hyperplasia; Patients > 18 yrs with classical or non classical CAH diagnosed during childhood
controls; control patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound evaluation of intima-media thickness	Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function	day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Peripheral	day 1
Skin capillary density		day 1
Insulin during an oral glucose tolerance test		day 1
Circulating cardiovascular risk markers	Interleukin-6	day 1
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	Calculated from pediatric and adult files	day 1
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	Central	day 1
Circulating cardiovascular risk markers	hsCRP	day 1
Circulating cardiovascular risk markers	adiponectin	day 1

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Anne Bachelot, MD, PhD, APHP

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: November 16, 2012
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (Estimate): March 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 16, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Cardiovascular risk; Microvascular dysfunction; Congenital adrenal hyperplasia (CAH)
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Endocrine System Diseases; Gonadal Disorders; Disorders of Sex Development; Urogenital Abnormalities; Congenital Abnormalities; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Adrenal Gland Diseases; Steroid Metabolism, Inborn Errors; Hyperplasia; Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Adrenocortical Hyperfunction
• Other Study ID Numbers: AOR 10032; P091106 (Other Identifier: APHP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO