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Assessment of Asymptomatic Heart Disease in Children With HIV

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00426374
Recruitment Status : Unknown
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was:  Not yet recruiting
First Posted : January 24, 2007
Last Update Posted : February 1, 2007
Information provided by:
Hadassah Medical Organization

Brief Summary:
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 or disease Intervention/treatment Phase
HIV Infections Procedure: echocardiography and blood test Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Infants and children congenitally infected with HIV-1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00426374

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Contact: Diana Averbuch, MD 972-50-7874940
Contact: Hadas Lemberg, PhD 00 972 2 6777572

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Hadassah University Hospital, Pediatric Department, Pediatric AIDS Center
Jerusalem, Israel, 91120
Contact: Diana Averbuch, MD    972-50-7874940   
Contact: Dan Engelhard, MD    972-2-6778960   
Principal Investigator: Diana Averbuch, MD         
Principal Investigator: Dan Engelhard, MD         
Sub-Investigator: Amiram Nir, MD         
Sub-Investigator: Azaria Rein, MD         
Sponsors and Collaborators
Hadassah Medical Organization
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Principal Investigator: Diana Averbuch, MD Hadassah University Hospital, Jerusalem, Israel
Layout table for additonal information Identifier: NCT00426374    
Other Study ID Numbers: yael11-HMO-CTIL
First Posted: January 24, 2007    Key Record Dates
Last Update Posted: February 1, 2007
Last Verified: January 2007
Keywords provided by Hadassah Medical Organization:
natriuretic peptide
heart failure
heart disease children
HIV pediatric
AIDS pediatric
Additional relevant MeSH terms:
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HIV Infections
Heart Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Cardiovascular Diseases