HIV-Associated Heart Disease
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Myocardial Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005229
First Posted
May 25, 2000
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005229
Brief Title
HIV-Associated Heart Disease
Study Type
Observational
2. Study Status
Record Verification Date
December 2001
Overall Recruitment Status
Completed
Study Start Date
July 1988 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 1993 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Heart Diseases, Myocardial Diseases, Acquired Immunodeficiency Syndrome, HIV Infections
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
2248200
Citation
Turco M, Seneff M, McGrath BJ, Hsia J. Cardiac tamponade in the acquired immunodeficiency syndrome. Am Heart J. 1990 Dec;120(6 Pt 1):1467-8. doi: 10.1016/0002-8703(90)90271-x. No abstract available.
Results Reference
background
PubMed Identifier
2167330
Citation
Hsia J, Goldstein AL, Simon GL, Sztein M, Hayden FG. Peripheral blood mononuclear cell interleukin-2 and interferon-gamma production, cytotoxicity, and antigen-stimulated blastogenesis during experimental rhinovirus infection. J Infect Dis. 1990 Sep;162(3):591-7. doi: 10.1093/infdis/162.3.591.
Results Reference
background
PubMed Identifier
2156009
Citation
Porter-Jordan K, Rosenberg EI, Keiser JF, Gross JD, Ross AM, Nasim S, Garrett CT. Nested polymerase chain reaction assay for the detection of cytomegalovirus overcomes false positives caused by contamination with fragmented DNA. J Med Virol. 1990 Feb;30(2):85-91. doi: 10.1002/jmv.1890300202.
Results Reference
background
PubMed Identifier
1746436
Citation
Rodriguez ER, Nasim S, Hsia J, Sandin RL, Ferreira A, Hilliard BA, Ross AM, Garrett CT. Cardiac myocytes and dendritic cells harbor human immunodeficiency virus in infected patients with and without cardiac dysfunction: detection by multiplex, nested, polymerase chain reaction in individually microdissected cells from right ventricular endomyocardial biopsy tissue. Am J Cardiol. 1991 Dec 1;68(15):1511-20. doi: 10.1016/0002-9149(91)90288-v.
Results Reference
background
PubMed Identifier
1951082
Citation
Hsia J, Colan SD, Adams S, Ross AM. Late potentials and their relation to ventricular function in human immunodeficiency virus infection. Am J Cardiol. 1991 Nov 1;68(11):1216-20. doi: 10.1016/0002-9149(91)90196-r.
Results Reference
background
PubMed Identifier
8017317
Citation
Hsia J, Ross AM. Pericardial effusion and pericardiocentesis in human immunodeficiency virus infection. Am J Cardiol. 1994 Jul 1;74(1):94-6. doi: 10.1016/0002-9149(94)90501-0. No abstract available.
Results Reference
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HIV-Associated Heart Disease
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