NCT00624949

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

Longer than P75 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2008

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 28, 2008

Status Verified

February 1, 2008

Enrollment Period

8.8 years

First QC Date

February 19, 2008

Last Update Submit

February 27, 2008

Conditions

Keywords

Turner syndromeaortic dimensionsblood pressureaortic dilatationaortic rupture

Outcome Measures

Primary Outcomes (1)

  • Aortic diameter at 3 well-defined levels measured by MRI and ECHO

    2-yearly for 6 years

Secondary Outcomes (1)

  • 24hour ambulatory blood pressure

    24h 2-yearly for 6 years

Study Arms (2)

1

women with Turner syndrome

2.

Control women

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recrutted from hospital clinics and through the patient organisation

You may qualify if:

  • Turner syndrome
  • Age 18-70 years

You may not qualify if:

  • Extreme adipositas
  • Contraindications to a MRI scan
  • Malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

  • Trolle 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.

  • Trolle 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.

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Turner SyndromeAortic Rupture

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine System DiseasesAneurysm, RupturedAneurysmVascular DiseasesAortic AneurysmAortic DiseasesRuptureWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 28, 2008

Study Start

August 1, 2003

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 28, 2008

Record last verified: 2008-02