Assessment of Asymptomatic Heart Disease in Children With HIV

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00426374
First received: January 23, 2007
Last updated: January 31, 2007
Last verified: January 2007
  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

Study Type: Interventional
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).

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
ClinicalTrials.gov Identifier: NCT00426374     History of Changes
Other Study ID Numbers: yael11-HMO-CTIL
Study First Received: January 23, 2007
Last Updated: January 31, 2007
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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on September 30, 2014