Congenital Adrenal HyperplasiacardiohcsNCT01807364
Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia
An observational study of Congenital Adrenal Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Congenital Adrenal Hyperplasia
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients > 18 yrs with classical or non classical CAH diagnosed during childhood and controls
Who may be able to join
- 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
- Age > 18 yrs
- Absence of known cardiovascular disease
- Absence of combined oral contraceptives during the previous month
Who cannot join
- Blood donation during the previous 3 months
- Cardiovascular disease
- Treatment by combined oral contraceptives
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Congenital Adrenal Hyperplasia
- Keywords
- Congenital adrenal hyperplasia (CAH), Cardiovascular risk, Microvascular dysfunction
- Medical subject headings
- Adrenal Hyperplasia, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Congenital adrenal hyperplasia | Patients > 18 yrs with classical or non classical CAH diagnosed during childhood | |
| controls | control patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound evaluation of intima-media thickness
Ultrasound evaluation of intima-media thickness at common carotids, carotid bulbs and left ventricular function
Measured: day 1
Secondary outcomes (14)
Blood pressure
Peripheral
Measured: day 1
Skin capillary density
Measured: day 1
Insulin during an oral glucose tolerance test
Measured: day 1
Circulating cardiovascular risk markers
Interleukin-6
Measured: day 1
Lipid profile
Measured: day 1
Lean mass measured by dual-energy X-ray absorptiometry
Measured: day 1
Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files
Calculated from pediatric and adult files
Measured: day 1
Pulse-wave velocity
Measured: day 1
Glucose during an oral glucose tolerance test
Measured: day 1
Anthropometry measured by dual-energy X-ray absorptiometry
Measured: day 1
Fat measured by dual-energy X-ray absorptiometry
Measured: day 1
Blood pressure
Central
Measured: day 1
Circulating cardiovascular risk markers
hsCRP
Measured: day 1
Circulating cardiovascular risk markers
adiponectin
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startMay 2011
- Primary completionSep 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Adrenal HyperplasiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Bachelot, MD, PhD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807364
- Sponsor's protocol ID
- AOR 10032
- Other IDs
- P091106
- Acronym
- cardiohcs
- Status last verified
- May 2016
- First submitted
- 16 Nov 2012
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cardiovascular Risk Profile in Adult Patients With Congenital Adrenal Hyperplasia Due to 21-hydroxylase Deficiency Diagnosed During Childhood
- ClinicalTrials.gov ID
- NCT01807364
- Acronym / sponsor ID
- cardiohcs / AOR 10032
- Conditions
- Congenital Adrenal Hyperplasia
- Keywords
- Congenital adrenal hyperplasia (CAH), Cardiovascular risk, Microvascular dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Congenital adrenal hyperplasia | – | –Patients > 18 yrs with classical or non classical CAH diagnosed during childhood |
| controls | – | –control patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 yrs with classical or non classical CAH diagnosed during childhood and controls
Key inclusion criteria (6 listed)
- 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
- Age > 18 yrs
- Absence of known cardiovascular disease
Key exclusion criteria (4 listed)
- Blood donation during the previous 3 months
- Cardiovascular disease
- Treatment by combined oral contraceptives
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
14 secondary outcomes
Blood pressure
Time frame: day 1
Skin capillary density
Time frame: day 1
Insulin during an oral glucose tolerance test
Time frame: day 1
Circulating cardiovascular risk markers
Time frame: day 1
Lipid profile
Time frame: day 1
Lean mass measured by dual-energy X-ray absorptiometry
Time frame: day 1
Total cumulative dose of glucocorticoid will be calculated from pediatric and adult files
Time frame: day 1
Pulse-wave velocity
Time frame: day 1
Glucose during an oral glucose tolerance test
Time frame: day 1
Anthropometry measured by dual-energy X-ray absorptiometry
Time frame: day 1
Fat measured by dual-energy X-ray absorptiometry
Time frame: day 1
Blood pressure
Time frame: day 1
Circulating cardiovascular risk markers
Time frame: day 1
Circulating cardiovascular risk markers
Time frame: day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: No
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RecruitingPhase 4
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Bachelot, MD, PhD principal investigator
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Adrenal Hyperplasia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound evaluation of intima-media thickness (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2016.