Cardiac disease in adolescents with perinatal HIV infection and receiving antiretroviral therapy

Characterisation Of caRdiac Disease in adolescents with perinatally-acquired HIV infection in the antiretroviral therapy era

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN10699064

Enrollment

120

Registered

2022-06-06

Start date

2022-09-01

Completion date

Unknown

Last updated

2026-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial disease in adolescents with perinatal HIV and receiving antiretroviral therapy (ART) Circulatory System

Interventions

Electronic clinic data and patient-held records will be used to confirm clinical and ART history. A clinical questionnaire will be administered by the research nurse to record demographic, prior medic

Eligibility

Sex/Gender

All

Age

10 Years to 19 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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 2. Cardiac functional abnormalities measured by RV and LV ejection fractions, systolic and diastolic strain rate on CMR at a single timepoint 3. Myocardial fibrosis measured by presence and extent (%) of late-gadolinium enhancement at a single timepoint	—

Measure

Time frame

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 2. Cardiac functional abnormalities measured by RV and LV ejection fractions, systolic and diastolic strain rate on CMR at a single timepoint 3. Myocardial fibrosis measured by presence and extent (%) of late-gadolinium enhancement at a single timepoint

—

Secondary

Measure	Time frame
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 2. CMV DNAemia measured by quantitative polymerase chain reaction at a single timepoint 3. Risk factors for cardiac abnormalities measured by CMR at a single timepoint 4. Association between biomarkers, CMV DNAemia and cardiac abnormalities measured by multivariable statistical analysis at a single timepoint	—

Measure

Time frame

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 2. CMV DNAemia measured by quantitative polymerase chain reaction at a single timepoint 3. Risk factors for cardiac abnormalities measured by CMR at a single timepoint 4. Association between biomarkers, CMV DNAemia and cardiac abnormalities measured by multivariable statistical analysis at a single timepoint

—

Countries

Zimbabwe

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 27, 2026