Assessment of Asymptomatic Heart Disease in Children With HIV
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Evaluation of the Cardiac Complications in Congenitally HIV-1 Infected Children in Israel by the Echocardiography and Measurement of N-Terminal Pro-B-Type Natriuretic Peptide (N-BNP).|
|Study Start Date:||January 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00426374
|Contact: Diana Averbuch, MDemail@example.com|
|Contact: Hadas Lemberg, PhD||00 972 2 firstname.lastname@example.org|
|Hadassah University Hospital, Pediatric Department, Pediatric AIDS Center||Recruiting|
|Jerusalem, Israel, 91120|
|Contact: Diana Averbuch, MD 972-50-7874940 email@example.com|
|Contact: Dan Engelhard, MD 972-2-6778960 firstname.lastname@example.org|
|Principal Investigator: Diana Averbuch, MD|
|Principal Investigator: Dan Engelhard, MD|
|Sub-Investigator: Amiram Nir, MD|
|Sub-Investigator: Azaria Rein, MD|
|Principal Investigator:||Diana Averbuch, MD||Hadassah University Hospital, Jerusalem, Israel|