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Assessment of Asymptomatic Heart Disease in Children With HIV

This study is not yet open for participant recruitment.
Verified by Hadassah Medical Organization, January 2007

Sponsored by: Hadassah Medical Organization
Information provided by: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00426374
  Purpose

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   

U.S. FDA Resources

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).

Further study details as provided by Hadassah Medical Organization:

Study Start Date:   January 2007

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Infants and children congenitally infected with HIV-1
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00426374

Contacts
Contact: Diana Averbuch, MD     972-50-7874940     dina8282@walla.co.il    
Contact: Hadas Lemberg, PhD     00 972 2 6777572     lhadas@hadassah.org.il    

Locations
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            

Sponsors and Collaborators
Hadassah Medical Organization

Investigators
Principal Investigator:     Diana Averbuch, MD     Hadassah University Hospital, Jerusalem, Israel    
  More Information


Publications:

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

Keywords provided by Hadassah Medical Organization:
HIV  
AIDS  
Troponin  
natriuretic peptide  
heart failure  
heart disease children
HIV pediatric
AIDS pediatric
heart disease children

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Virus Diseases
Sexually Transmitted Diseases, Viral
Heart Failure
Heart Diseases
HIV Infections
Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Retroviridae Infections
Immunologic Deficiency Syndromes

Additional relevant MeSH terms:
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs
Lentivirus Infections
Cardiovascular Diseases
Cardiovascular Agents
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 23, 2008




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