- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02124109
The Genetic Basis of Acquired Heart Disease in Africa
Background:
- An acquired heart disease is one that a person gets after they are born. Two of these are rheumatic heart disease (RHD) and endomyocardial fibrosis (EMF). They are found more commonly in people who live in Africa than in other places in the world. Researchers want to learn more about these diseases. They especially want to know what role genes and other factors play in them.
Objective:
- To identify genetic risk factors for RHD and EMF in sub-Saharan Africa.
Eligibility:
- Children and adults with RHD or EMF.
- Healthy volunteers over age 10.
Design:
- Participants will come from existing study groups in Uganda and Nigeria.
- Participants may be required to provide a sample of their DNA. They will do this with either a blood or saliva sample or a swab of the mouth.
- Collected samples will be labeled with a code and sent to a lab in the United States for analysis. Remaining portions of participants samples will be stored for an unlimited period of time. They may be used in future studies.
- Some genetic and health information from participants might be placed into one or more scientific databases.
- Participant names and identifying information will be kept private. But there is a small chance someone could trace them from their genetic information.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
- Rheumatic Heart Disease:
Patients with a definite diagnosis of rheumatic heart disease based on the 2006 World Health Organization/National Institutes of Health Joint Criteria (http://www.niaid.nih.gov/topics/strepThroat/Documents/groupasequelae.pdf) controls who do not meet this criteria. The diagnosis will be made by a cardiologist on our team. The method of screening and recruitment will be specific to each of our two sites: Uganda Heart Institute and University of Lagos, Nigeria.
-Uganda Heart Institute:
--recruitment will be conducted from an existing cohort of patients initially recruited by members of our team from 21 randomly selected
schools in Uganda. Participants meeting the criteria noted above for RHD will be considered cases and those who do not will be considered controls. Additionally, parents will be invited to participate as controls. For controls, only children over age 10 will be considered as this increases the likelihood of exposure
to S. pyogenes. The initial study was approved by the institutional review boards of the Children s National Medical Center (Washington,D.C.), Makerere University (Kampala, Uganda), and the
Ugandan Ministries of Health and Education
University of Lagos:
--This program will be modeled after the Uganda program. Participants will be screened for RHD at the College of Medicine or at randomly selected schools. Participants meeting criteria for RHD will be consented as cases and those negative for RHD will be consented as controls. Additionally, parents will be invited to participate as controls. For controls, only children over age 10 will be considered as this increases the likelihood of exposure to S. pyogenes
Endomyocardial Fibrosis (EMF):
- Cases: the study will include patients with a diagnosis of EMF based on echocardiography, history, and physical exam performed by cardiologist;on our team Over 50 patients have been identified at the Uganda Heart Institute with EMF and will be contacted for study participation; additionally, newly diagnosed patients at the Uganda Heart Institute will be offered participation.
- Controls: Geographic and age matched controls will be used for association study. Controls will be disease free, based on above criteria. We will exclude controls less than 15 years of age based on disease peak around age 10. Controls will be selected from those being screening for RHD
EXCLUSION CRITERIA:
-Anyone unwilling to provide informed consent (for themselves as adults, or on behalf of their children as minors) or assent.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
---|
Control
Control group
|
rheumatic heart disease
Patients with rheumatic heart disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Extension of study
Time Frame: ongoing
|
Extend our previous epidemiological studies of RHD in Ugandan schoolchildren (Beaton et al 2012) by conducting a similar study ofRHD in Nigerian children
|
ongoing
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul S Kruszka, M.D., National Human Genome Research Institute (NHGRI)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study 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
- Cardiovascular Diseases
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Arthritis
- Bacterial Infections
- Bacterial Infections and Mycoses
- Streptococcal Infections
- Gram-Positive Bacterial Infections
- Cardiomyopathies
- Heart Diseases
- Rheumatic Diseases
- Rheumatic Fever
- Rheumatic Heart Disease
- Endomyocardial Fibrosis
Other Study ID Numbers
- 999914098
- 14-HG-N098
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.
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