Turner SyndromeNCT00624949
Aortic Dimensions in Turner Syndrome
An observational study of Turner Syndrome, run by University of Aarhus.
Trial summary
An observational study of 102 women with Turner syndrome followed for 6 years with a two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It has been found that besides an significantly increased risk of congenital cardiac malformations, TS have an increased risk of developing… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Turner Syndrome
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Jun 2012
- 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 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Recrutted from hospital clinics and through the patient organisation
Who may be able to join
- Turner syndrome
- Age 18-70 years
Who cannot join
- Extreme adipositas
- Contraindications to a MRI scan
- Malignant disease
About this study
Official title: Aortic Dimensions, 24hour Ambulatory Blood Pressure and Sympathovagal Tone in Turner Syndrome. In Relation to Aortic Dilatation and Dissection.
An observational study of 102 women with Turner syndrome followed for 6 years with a two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It has been found that besides an significantly increased risk of congenital cardiac malformations, TS have an increased risk of developing cardiac disease including the life threatening condition of aortic dilatation and rupture. The aim of the study is to describe the cardiac conditions of TS, evaluate different methods of examination and identify possible risc factors.
- Conditions
- Turner Syndrome
- Keywords
- Turner syndrome, aortic dimensions, blood pressure, aortic dilatation, aortic rupture
- Medical subject headings
- Turner Syndrome, Aortic Rupture
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 |
|---|---|---|
| 1 | women with Turner syndrome | |
| 2. | Control women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic diameter at 3 well-defined levels measured by MRI and ECHO
Measured: 2-yearly for 6 years
Secondary outcomes (1)
24hour ambulatory blood pressure
Measured: 24h 2-yearly for 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2008 (estimated)
- Study startAug 2003
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Turner SyndromeStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00624949
- Sponsor's protocol ID
- 20010248
- Status last verified
- Feb 2008
- First submitted
- 19 Feb 2008
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Viuff M, Skakkebaek A, Johannsen EB, Chang S, Pedersen SB, Lauritsen KM, Pedersen MGB, Trolle C, Just J, Gravholt CH. X chromosome dosage and the genetic impact across human tissues. Genome Med. 2023 Mar 28;15(1):21. doi: 10.1186/s13073-023-01169-4.
PubMed 36978128Trolle C, Mortensen KH, Bjerre M, Hougaard DM, Cohen A, Andersen NH, Gravholt CH. Osteoprotegerin in Turner syndrome - relationship to aortic diameter. Clin Endocrinol (Oxf). 2015 Mar;82(3):397-403. doi: 10.1111/cen.12522. Epub 2014 Jul 2.
PubMed 24923356Trolle C, Mortensen KH, Pedersen LN, Berglund A, Jensen HK, Andersen NH, Gravholt CH. Long QT interval in Turner syndrome--a high prevalence of LQTS gene mutations. PLoS One. 2013 Jul 25;8(7):e69614. doi: 10.1371/journal.pone.0069614. Print 2013.
PubMed 23936059
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Dimensions, 24hour Ambulatory Blood Pressure and Sympathovagal Tone in Turner Syndrome. In Relation to Aortic Dilatation and Dissection.
- ClinicalTrials.gov ID
- NCT00624949
- Acronym / sponsor ID
- 20010248
- Conditions
- Turner Syndrome
- Keywords
- Turner syndrome, aortic dimensions, blood pressure, aortic dilatation, aortic rupture
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 28 Feb 2008 (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.
An observational study of 102 women with Turner syndrome followed for 6 years with a two-yearly examination including ECHO, MRI of the heart and 24 ambulatory blood pressure. It has been found that besides an significantly increased risk of congenital cardiac malformations, TS have an increased risk of developing cardiac disease including the life threatening condition of aortic dilatation and rupture. The aim of the study is to describe the cardiac conditions of TS, evaluate different methods of examination and identify possible risc factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –women with Turner syndrome |
| 2. | – | –Control women |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Recrutted from hospital clinics and through the patient organisation
Key inclusion criteria (2 listed)
- Turner syndrome
- Age 18-70 years
Key exclusion criteria (3 listed)
- Extreme adipositas
- Contraindications to a MRI scan
- Malignant disease
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
Aortic diameter at 3 well-defined levels measured by MRI and ECHO
Time frame: 2-yearly for 6 years
1 secondary outcome
24hour ambulatory blood pressure
Time frame: 24h 2-yearly for 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2008.
- Derived from this study: PubMed 36978128Viuff M, Skakkebaek A, Johannsen EB, Chang S, Pedersen SB, Lauritsen KM, Pedersen MGB, Trolle C, Just J, Gravholt CH. X chromosome dosage and the genetic impact across human tissues. Genome Med. 2023 Mar 28;15(1):21. doi: 10.1186/s13073-023-01169-4.
- Derived from this study: PubMed 24923356Trolle C, Mortensen KH, Bjerre M, Hougaard DM, Cohen A, Andersen NH, Gravholt CH. Osteoprotegerin in Turner syndrome - relationship to aortic diameter. Clin Endocrinol (Oxf). 2015 Mar;82(3):397-403. doi: 10.1111/cen.12522. Epub 2014 Jul 2.
- Derived from this study: PubMed 23936059Trolle C, Mortensen KH, Pedersen LN, Berglund A, Jensen HK, Andersen NH, Gravholt CH. Long QT interval in Turner syndrome--a high prevalence of LQTS gene mutations. PLoS One. 2013 Jul 25;8(7):e69614. doi: 10.1371/journal.pone.0069614. Print 2013.
Related trials for Turner Syndrome
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Active, not recruitingPhase 2
Efficacy and Safety of Phentermine/Topiramate in Youth With Hypothalamic Obesity
Hypothalamic Obesity, Hypothalamic Tumor
Active, not recruitingPhase 1/2
A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment
Hypothalamic Obesity, Prader-Willi Syndrome
RecruitingObservational study
Turner Syndrome: Genetic Considerations
Genetic
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Turner Syndrome, run by University of Aarhus.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Aortic diameter at 3 well-defined levels measured by MRI and ECHO (time frame: 2-yearly for 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00624949, which also lists 3 linked publications.
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 28 Feb 2008.