Assessment of Asymptomatic Heart Disease in Children With HIV

Hadassah Medical Center

Status: Unknown

Conditions: HIV Infections

Treatments: Procedure: echocardiography and blood test

Study type: Interventional

Funder types: Other

Identifiers

NCT00426374

yael11-HMO-CTIL

Details and patient eligibility

About

The purpose of this study is to perform cardiac evaluation in HIV-1 (predominantly clade C)infected children by history, physical examination, echocardiogram and plasma N-terminal pro-B-type natriuretic peptide (N-BNP)measurement in order to determine asymptomatic abnormalities.

Full description

Human immunodeficiency virus (HIV) infection affects nearly 40 million adults and children worldwide. Recently introduced new antiviral drugs have significantly improved survival of patients with HIV infection. As mortality declines, morbidity becomes a concern. Heart disease is present in 20% of children and adults with HIV. The cardiac diseases include left ventricular dysfunction, hypertrophy and dilation, pericardial effusion and intracardiac masses. Cardiac disease is an independent risk factor for death in these children. The reported two-year survival of children with congestive heart failure is zero compared to 17% when no heart failure is present. It is thus indicated to perform periodic cardiac examinations in these patients, and early recognition of cardiac disease is paramount.

In addition to the traditional tools to assess cardiac status which include history, physical examination, ECG, chest X-ray and echocardiography, we propose to check biochemical markers. Brain natriuretic peptide has been shown to be a very sensitive marker for symptomatic and asymptomatic cardiac dysfunction, prognosis, severity of the disease and response to therapy in adults. Troponin-T is a very good marker for cardiac ischemia. Recently, we have found troponin-T to be a good marker for acute cardiac insult in infants and children.

The aim of this study is to perform screening of children with HIV predominantly clade C for cardiac disease using the above mentioned means.

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Infants and children congenitally infected with HIV-1

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)