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Sponsored by: |
Hadassah Medical Organization |
Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00426374 |
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.
Condition | Intervention |
HIV Infections |
Procedure: echocardiography and blood test |
MedlinePlus related topics: | AIDS Heart Diseases |
ChemIDplus related topics: | Nesiritide Proline |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Diana Averbuch, MD | 972-50-7874940 | dina8282@walla.co.il |
Contact: Hadas Lemberg, PhD | 00 972 2 6777572 | lhadas@hadassah.org.il |
Israel | |||||
Hadassah University Hospital, Pediatric Department, Pediatric AIDS Center | Recruiting | ||||
Jerusalem, Israel, 91120 | |||||
Contact: Diana Averbuch, MD 972-50-7874940 dina8282@walla.co.il | |||||
Contact: Dan Engelhard, MD 972-2-6778960 engelhard@hadassah.org.il | |||||
Principal Investigator: Diana Averbuch, MD | |||||
Principal Investigator: Dan Engelhard, MD | |||||
Sub-Investigator: Amiram Nir, MD | |||||
Sub-Investigator: Azaria Rein, MD |
Hadassah Medical Organization |
Principal Investigator: | Diana Averbuch, MD | Hadassah University Hospital, Jerusalem, Israel |
Study ID Numbers: | yael11-HMO-CTIL |
First Received: | January 23, 2007 |
Last Updated: | January 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00426374 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
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