- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00497705
Genes Causing Ebstein's Anomaly
Genes Causing Congenital Ebstein's Anomaly
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.
Study Overview
Status
Detailed Description
Study Type
Contacts and Locations
Study Locations
-
-
-
Republic of Belarus, Belarus
- Republican Scientific and Clinical Cardiology Center
-
-
-
-
-
Kyiv, Ukraine
- Amosov Institute of Cardiovascular Surgery
-
-
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center, 9000 Rockville Pike
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- INCLUSION CRITERIA:
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.
EXCLUSION CRITERIA:
There are no exclusion criteria. This may allow us to discover previously unknown relationships between Ebstein's anomaly and other diseases.
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Nat Genet 1997 Apr;15(4):411.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Cardiovascular Abnormalities
- Heart Septal Defects, Ventricular
- Transposition of Great Vessels
- Aortopulmonary Septal Defect
- Congenital Abnormalities
- Heart Septal Defects
- Heart Defects, Congenital
- Ebstein Anomaly
- Double Outlet Right Ventricle
- Truncus Arteriosus, Persistent
Other Study ID Numbers
- 070186
- 07-H-0186
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Defects, Congenital
-
Oslo University HospitalUniversity of BergenCompletedHeart Septal Defects, Atrial | Heart Defects,CongenitalNorway
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Heart Septal Defects, Atrial | Heart Septal Defects, Ventricular | Endocardial Cushion Defects | Defect, Congenital Heart
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedHeart Diseases | Cardiovascular Diseases | Heart Septal Defects, Atrial | Heart Septal Defects, Ventricular | Endocardial Cushion Defects | Defect, Congenital Heart
-
SeptRx, Inc.UnknownHeart Septal Defects | Heart Defects, Congenital | Foramen Ovale, PatentGermany, France
-
Medtronic Heart ValvesCompletedDysfunctional RVOT Conduits in Patients With Congenital Heart DefectsSpain, United States, Austria, Canada
-
Zhengzhou UniversityNot yet recruitingCongenital Heart DefectChina
-
Children's Hospital of Eastern OntarioHeart and Stroke Foundation of CanadaRecruitingCongenital Heart DefectCanada
-
Medical College of WisconsinNational Center for Research Resources (NCRR); Children's Hospital and Health...Terminated
-
Ain Shams UniversityCompletedHeart Defects, CongenitalEgypt
-
Oslo University HospitalBioPhausiaCompletedHeart Defects, Congenital | Transposition of Great Vessels | Heart Septal Defects, Ventricular | Endocardial Cushion Defects