Cardiac disease in adolescents with perinatal HIV infection and receiving antiretroviral therapy
Not Applicable
- Conditions
- Circulatory SystemMyocardial disease in adolescents with perinatal HIV and receiving antiretroviral therapy (ART)
- Registration Number
- ISRCTN10699064
- Lead Sponsor
- Biomedical Research and Training Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
1. Aged 10-19 years
2. Adolescents with HIV taking ART for at least 6 months
3. Adolescents without HIV for the comparison group
Exclusion Criteria
1. Contra-indications to CMR (implantable cardiac devices, pacemakers, and claustrophobia)
2. Severe renal impairment (defined as an estimated glomerular filtration rate (eGFR) <30 ml/min)
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Cardiac structural abnormalities measured by left ventricular (LV) mass and LV mass index; LV and right ventricular (RV) volumes, LV wall thickness on cardiac magnetic resonance imaging (CMR) at a single timepoint<br>2. Cardiac functional abnormalities measured by RV and LV ejection fractions, systolic and diastolic strain rate on CMR at a single timepoint<br>3. Myocardial fibrosis measured by presence and extent (%) of late-gadolinium enhancement at a single timepoint
- Secondary Outcome Measures
Name Time Method 1. Biomarkers of cardiac disease, fibrosis and inflammation (GDF-15, Troponin-I, NT-proBNP, ST2, CRP, IL-6, TNF-alpha, soluble CD14, Galectin-3, TIMP-1) measured by Luminex technology in plasma at a single timepoint<br>2. CMV DNAemia measured by quantitative polymerase chain reaction at a single timepoint<br>3. Risk factors for cardiac abnormalities measured by CMR at a single timepoint<br>4. Association between biomarkers, CMV DNAemia and cardiac abnormalities measured by multivariable statistical analysis at a single timepoint