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Completed

NCT Number: NCT01807364

Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia

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.

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ultrasound evaluation of intima-media thickness

    Time frame: day 1

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

Secondary outcomes

  1. Blood pressure

    Time frame: day 1

    Peripheral

  2. Skin capillary density

    Time frame: day 1

  3. Insulin during an oral glucose tolerance test

    Time frame: day 1

  4. Circulating cardiovascular risk markers

    Time frame: day 1

    Interleukin-6

  5. Lipid profile

    Time frame: day 1

  6. Lean mass measured by dual-energy X-ray absorptiometry

    Time frame: day 1

  7. Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files

    Time frame: day 1

    Calculated from pediatric and adult files

  8. Pulse-wave velocity

    Time frame: day 1

  9. Glucose during an oral glucose tolerance test

    Time frame: day 1

  10. Anthropometry measured by dual-energy X-ray absorptiometry

    Time frame: day 1

  11. Fat measured by dual-energy X-ray absorptiometry

    Time frame: day 1

  12. Blood pressure

    Time frame: day 1

    Central

  13. Circulating cardiovascular risk markers

    Time frame: day 1

    hsCRP

  14. Circulating cardiovascular risk markers

    Time frame: day 1

    adiponectin

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: cardiohcs

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Mar 8, 2013
Registry last updated
Jun 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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