Ped HIV - Echo Study: Kenya

NCT03228966 | Completed FDA Device

• 1 other identifier: Pro00083416
• Study Type: observational
• Target: 643
• Locations: 1 country
• Sites: 1

Brief 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

HIV/AIDS; Cardiomyopathies

Keywords

Pediatric

Outcome Measures

Primary Outcomes (3)

• Cardiac function inversely associated with HIV viral load

  Day of clinic visit laboratory results

• Cardiac function inversely associated with inflammatory marker levels

  Day of clinic visit laboratory results

• Cardiac function inversely associated with bio-marker levels

  Day of clinic visit

Interventions

Echocardiogram DIAGNOSTIC_TEST

Screening echocardiogram

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children living with HIV attending regular scheduled follow up visit.

You may qualify if:

• Attending HIV care clinic for regular follow up visit
• \< 14 years old
• Diagnosed HIV prior to age 10
• caregiver gives consent

You may not qualify if:

• unable to cooperate with echocardiogram

Sponsors & Collaborators

• Duke University: lead
• Duke Center for AIDS Research: collaborator
• International AIDS Society: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma for viral load and inflammatory marker testing

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiomyopathies

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Andrew W McCrary, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 25, 2017
• Study Start: September 12, 2017
• Primary Completion: December 30, 2018
• Study Completion: December 30, 2018
• Last Updated: August 1, 2019

Record last verified: 2019-07

Locations

KE (1)