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Assessment of Asymptomatic Heart Disease in Children With HIV

Primary Purpose

HIV Infections

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

echocardiography and blood test

About this trial

This is an interventional diagnostic trial for HIV Infections focused on measuring HIV, AIDS, Troponin, natriuretic peptide, heart failure, heart disease children, HIV pediatric, AIDS pediatric

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Infants and children congenitally infected with HIV-1

Sites / Locations

Hadassah University Hospital, Pediatric Department, Pediatric AIDS Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00426374

First Posted

January 23, 2007

Last Updated

January 31, 2007

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00426374

Brief Title

Assessment of Asymptomatic Heart Disease in Children With HIV

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 Type

Interventional

2. Study Status

Record Verification Date

January 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV Infections

Keywords

HIV, AIDS, Troponin, natriuretic peptide, heart failure, heart disease children, HIV pediatric, AIDS pediatric

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

echocardiography and blood test

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Infants and children congenitally infected with HIV-1

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Diana Averbuch, MD

Phone

972-50-7874940

dina8282@walla.co.il

First Name & Middle Initial & Last Name or Official Title & Degree

Hadas Lemberg, PhD

Phone

00 972 2 6777572

lhadas@hadassah.org.il

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diana Averbuch, MD

Organizational Affiliation

Hadassah University Hospital, Jerusalem, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah University Hospital, Pediatric Department, Pediatric AIDS Center

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Diana Averbuch, MD

Phone

972-50-7874940

dina8282@walla.co.il

First Name & Middle Initial & Last Name & Degree

Dan Engelhard, MD

Phone

972-2-6778960

engelhard@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Diana Averbuch, MD

First Name & Middle Initial & Last Name & Degree

Dan Engelhard, MD

First Name & Middle Initial & Last Name & Degree

Amiram Nir, MD

First Name & Middle Initial & Last Name & Degree

Azaria Rein, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

11762985

Citation

Keesler MJ, Fisher SD, Lipshultz SE. Cardiac manifestations of HIV infection in infants and children. Ann N Y Acad Sci. 2001 Nov;946:169-78. doi: 10.1111/j.1749-6632.2001.tb03911.x.

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Assessment of Asymptomatic Heart Disease in Children With HIV

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