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

This study is currently recruiting participants.
Verified November 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01807364
First received: November 16, 2012
Last updated: March 6, 2013
Last verified: November 2012
History of Changes
  Purpose

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
Congenital Adrenal Hyperplasia

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Ultrasound evaluation of intima-media thickness [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function


Secondary Outcome Measures:
  • Blood pressure [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Peripheral

  • Skin capillary density [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Insulin during an oral glucose tolerance test [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Circulating cardiovascular risk markers [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Interleukin-6

  • Lipid profile [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Lean mass measured by dual-energy X-ray absorptiometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Calculated from pediatric and adult files

  • Pulse-wave velocity [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Glucose during an oral glucose tolerance test [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Anthropometry measured by dual-energy X-ray absorptiometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Fat measured by dual-energy X-ray absorptiometry [ Time Frame: day 1 ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    Central

  • Circulating cardiovascular risk markers [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    hsCRP

  • Circulating cardiovascular risk markers [ Time Frame: day 1 ] [ Designated as safety issue: No ]
    adiponectin


Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 180
Study Start Date: May 2011
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Congenital adrenal hyperplasia
Patients > 18 yrs with classical or non classical CAH diagnosed during childhood
controls
control 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01807364

Contacts
Contact: Anne Bachelot, Md, PhD anne.bachelot@psl.aphp.fr

Locations
France
Pitié Salpêtrière Hospital Recruiting
Paris, France, 75013
Contact: Anne Bachelot     00 33 1 42 16 02 46        
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Anne Bachelot, MD, PhD APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01807364     History of Changes
Other Study ID Numbers: AOR 10032, P091106
Study First Received: November 16, 2012
Last Updated: March 6, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Congenital adrenal hyperplasia (CAH)
Cardiovascular risk
Microvascular dysfunction

Additional relevant MeSH terms:
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Hyperplasia
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Pathologic Processes
 Epinephrine
Epinephryl borate
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013