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HIV-Associated Heart Disease

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005229
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: December 2001

May 25, 2000
June 23, 2005
July 1988
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Complete list of historical versions of study NCT00005229 on ClinicalTrials.gov Archive Site
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HIV-Associated Heart Disease
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To develop natural history data regarding the incidence, clinical course, prognosis, and effects of treatment with anti-viral and immunosuppressive agents on HIV-associated heart disease. A second part of the study evaluated a number of possible mechanisms underlying the development of HIV heart disease.

BACKGROUND:

As AIDS reached epidemic proportions it became apparent that heart disease contributed to morbidity in this disease. By 1988, survival following diagnosis with AIDS had improved, and the impact of heart disease on quality of life and survival in these patients had increased in parallel. The spectrum of pathology which comprised AIDS heart disease was diverse and the contribution of cardiac disease to mortality was quite unclear. Unanswered questions included: which seropositive individuals would develop heart disease; what was the spectrum of heart disease in these patients; were there any useful parameters for risk stratification; what was the clinical course; was the etiology due to HIV or other infectious agents or immunologic; did anti-viral agents or immunosuppressive treatment affect the disease course?

This project was part of an Institute-initiated study on AIDS-Associated Heart Disease in Adults. The concept was approved by the National Heart, Lung, and Blood Advisory Council in September 1987. The Request for Applications was also released in September 1987. Awards were made in July 1988.

DESIGN NARRATIVE:

Asymptomatic patients were recruited from the azidothymidine (AZT) versus placebo trial, open label AZT trial, isoprinosine versus placebo trial, and Ampligen versus placebo trial at George Washington University Medical Center. Symptomatic patients were referred from nearby clinics. Baseline information collected included age, sex, weight, HIV risk factors, dates of seroconversion, total CD4 lymphocyte count, clinical symptoms, symptoms of AIDS-related complex, first opportunistic infection, development of tumors or neurologic symptoms, anti-viral therapy, chest pain, symptoms of and treatment for congestive heart failure, evidence of arrhythmia, and initiation of anti-arrhythmic therapy. Date and cause of death were recorded along with autopsy findings. Non-invasive serial electrocardiograms and echocardiograms were performed in all participants at baseline and every four months. Endomyocardial biopsy was performed in patients with congestive cardiomyopathy, those with echocardiographic evidence of left ventricular dysfunction or large pericardial effusions, and those with significant arrhythmias. Endomyocardial biopsies were obtained from ten asymptomatic individuals, five of whom had lymphadenopathy, and five of whom had no lymphadenopathy. Percutaneous pericardiocentesis was performed in patients with large pericardial effusions to obtain samples for bacterial, mycobacterial, HIV and cytomegalovirus cultures. The fact that the majority of these patients were participating in clinical trials of various anti-viral agents allowed evaluation of their effects on the development of heart disease. The second part of the project was a study of the pathogenesis of HIV-associated heart disease. Light and electron microscopic findings were examined in the heart at various clinical stages of HIV infection. Cardiocytes were examined for presence of HIV and other infectious agents.

Observational
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  • Cardiovascular Diseases
  • Heart Diseases
  • Myocardial Diseases
  • Acquired Immunodeficiency Syndrome
  • HIV Infections
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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June 1993
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No eligibility criteria

Male
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00005229
1109
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National Heart, Lung, and Blood Institute (NHLBI)
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National Heart, Lung, and Blood Institute (NHLBI)
December 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP