NCT00497705

Brief Summary

This study will investigate Ebstein's anomaly, a congenital abnormality of the tricuspid valve of the heart and try to identify the genetic origins of the disease. Adults and children 2 years of age and older with Ebstein's anomaly and healthy volunteers may be eligible for this study. Participants undergo the following procedures:

  • Blood tests: Three tube of blood will be collected, with the total amount limited to about half a teaspon for each two pounds of body weight.
  • Saliva sample collection: A small amount of saliva is collected by spitting into a sterile container.
  • Oral (cheek) swab: Cells are collected from the mouth using a soft brush to swab the inside lining of the cheek.
  • Electrocardiogram: The electrical activity of the heart is recorded using electrodes placed on the chest.
  • Echocardiogram: Heart function is assessed using ultrasound.

Trial Health

85
On Track

Trial Health Score

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

Geographic Reach
3 countries

3 active sites

Status
completed

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

July 3, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 9, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2009

Completed
Last Updated

July 2, 2017

Status Verified

July 7, 2009

Enrollment Period

2 years

First QC Date

July 6, 2007

Last Update Submit

June 30, 2017

Conditions

Keywords

Ebsteins AnomalyHeart Septal Defects, VentricleHeart Defects, CongenitalDouble Outlet Right VentricleTruncus Arteriosus PersistantEbstein's AnomalyCongenital Heart DiseaseHeart Defects

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have diagnosed Ebstein's anomaly or tricuspid valve disease in Belarus or Ukraine and their parents will be asked to participate in this study regardless of sex, age, or race. In addition, sex and age matched neighborhood children and their parents will be recruited as controls. There is no known ethnic or racial predilection for Ebstein's anomaly or tricuspid valve disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Republican Scientific and Clinical Cardiology Center

Republic of Belarus, Belarus

Location

Amosov Institute of Cardiovascular Surgery

Kyiv, Ukraine

Location

Related Publications (3)

  • Abu-Issa R, Waldo K, Kirby ML. Heart fields: one, two or more? Dev Biol. 2004 Aug 15;272(2):281-5. doi: 10.1016/j.ydbio.2004.05.016. No abstract available.

    PMID: 15282148BACKGROUND
  • Attenhofer Jost CH, Connolly HM, Dearani JA, Edwards WD, Danielson GK. Ebstein's anomaly. Circulation. 2007 Jan 16;115(2):277-85. doi: 10.1161/CIRCULATIONAHA.106.619338. No abstract available.

    PMID: 17228014BACKGROUND
  • Basson CT, Bachinsky DR, Lin RC, Levi T, Elkins JA, Soults J, Grayzel D, Kroumpouzou E, Traill TA, Leblanc-Straceski J, Renault B, Kucherlapati R, Seidman JG, Seidman CE. Mutations in human TBX5 [corrected] cause limb and cardiac malformation in Holt-Oram syndrome. Nat Genet. 1997 Jan;15(1):30-5. doi: 10.1038/ng0197-30.

    PMID: 8988165BACKGROUND

MeSH Terms

Conditions

Heart Septal DefectsHeart Defects, CongenitalDouble Outlet Right VentricleTruncus Arteriosus, PersistentEbstein Anomaly

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Septal Defects, VentricularTransposition of Great VesselsAortopulmonary Septal Defect

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

July 6, 2007

First Posted

July 9, 2007

Study Start

July 3, 2007

Primary Completion

July 7, 2009

Last Updated

July 2, 2017

Record last verified: 2009-07-07

Locations