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Ped HIV - Echo Study: Kenya

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clinicaltrials.gov/study/NCT03228966
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT032289660
Health Conditions in Trial
HIV/AIDS
HIV/AIDS
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Trial Recruitment Size
6430
Trial Sponsor
Duke University
Duke University
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Trial Collaborator
International AIDS Society
International AIDS Society
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Clinical Trial Start Date
September 12, 2017
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Primary Completion Date
December 30, 2018
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Study Completion Date
December 30, 2018
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Cross-Sectional0
Participating Facility
‌
Moi Teaching and Referral Hospital
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Official Name
Evaluating Indicators of Cardiac Function in Children Living With HIV in Western Kenya0
Last Updated
August 1, 2019
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Study summary

Background: In children and adults living with HIV, cardiomyopathy is a major source of comorbidity. Traditional echocardiographic measures are insensitive and consequently cardiomyopathy often goes undiagnosed until late stages of disease. Myocardial deformation imaging represents a promising means to identify early dysfunction, but to date there have been no large studies using strain or strain rate to assess cardiac function in children with HIV and to establish predictors of worse cardiac function such as viral burden and ART regimen. These studies are critically important as earlier diagnosis and intervention represent the best means to alter the course of HIV-associated cardiomyopathy. Objectives: To determine the association of biomarker levels, myocardial deformation, and viral load level history in HIV infected children attending Moi Teaching and Referral Hospital (MTRH) clinic. Design: A cross-sectional study on clients attending HIV clinic, MTRH. Setting: Module 4 HIV clinic at MTRH in western Kenya, Africa. Population: HIV-infected children attending clinic in 2017 - 2018 Main Measures: Echocardiographic function assessment, Age, Immune status, other illnesses, ART status. Conclusions: The study will explore the NIH/HIV High Priority Target area of HIV-associated cardiac co-morbidities and will enhance understanding of the relationship between cardiac function and viremia. The investigators expect to be able to reliably define a subset of children with worse cardiac function by risk factors: specific ART regimens, less time virally suppressed, and increased BNP biomarker.

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