MedTrace Logo

Ped HIV - Echo Study: Kenya

NCT03228966 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 643

Last updated 2019-08-01

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

Echocardiogram

Screening echocardiogram

Sponsors & Collaborators

  • Duke Center for AIDS Research

    collaborator UNKNOWN

  • International AIDS Society

    collaborator OTHER

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Duke University

    lead OTHER

Principal Investigators

  • Andrew W McCrary, MD · Duke University

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-12
Primary Completion
2018-12-30
Completion
2018-12-30
FDA Device
Yes

Countries

  • Kenya

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03228966 on ClinicalTrials.gov