CompletedNot Applicable

The Genetic Basis of Acquired Heart Disease in Africa

Nigeria, Uganda736 participantsStarted 2014-04-03

Plain-language summary

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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Uganda Heart Institute:
-recruitment will be conducted from an existing cohort of patients initially recruited by members of our team from 21 randomly selected
-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

Exclusion criteria

Anyone unwilling to provide informed consent (for themselves as adults, or on behalf of their children as minors) or assent.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Extension of study

Timeframe: ongoing

Trial details

NCT IDNCT02124109

SponsorNational Human Genome Research Institute (NHGRI)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2019-03-08

View on ClinicalTrials.gov More Rheumatic Heart Disease trials