AIDS-Associated Heart Disease -- Incidence and Etiology
Primary Purpose
Heart Diseases, Acquired Immunodeficiency Syndrome, Myocardial Diseases
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Heart Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005228
First Posted
May 25, 2000
Last Updated
March 15, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005228
Brief Title
AIDS-Associated Heart Disease -- Incidence and Etiology
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 detect by Doppler echocardiography the incidence of cardiac abnormalities in HIV-positive patients in a prospective, longitudinal study.
Detailed Description
BACKGROUND:
Cardiovascular abnormalities have been reported in Acquired Immunodeficiency Syndrome (AIDS) clinically, echocardiographically and at autopsy. Pericardial effusion, cardiac tamponade, echocardiographic abnormalities and clinical cardiomyopathy with right and left-sided congestive heart failure have all been reported as isolated case reports or in small retrospective series of patients with AIDS who had echocardiograms. The frequency with which abnormalities specifically related to AIDS were found in consecutively studied patients was not known in 1988 when the study began.
The etiology of these abnormalities was also unclear. Since HIV infection resulted in profound suppression of T-cell macrophage-mediated immunity in AIDS and since there were significant abnormalities in B-cell lymphocyte function resulting in abnormalities of humoral immunity, there were frequently life threatening superinfections by bacterial, fungal, parasitic, and viral organisms. Some of these, such as herpes simplex, cytomegalovirus, cryptococcosis, toxoplasmosis and histoplasmosis, were known to cause pericarditis and myocarditis in the absence of AIDS so the presence of definite myocardial disease in AIDS did not prove that the disease was due to the HIV organism.
Using echocardiography to study cardiac structure and function in a small series of patients with AIDS, abnormalities have been identified in from 25 to 75 percent of patients. All of these studies were retrospective; none was prospective with controls. Furthermore, all types of echocardiographic abnormalities have been described including the presence of pericardial fluid, mitral valve prolapse, chamber size abnormalities, and wall motion abnormalities. Although these abnormalities could have been due to infection with the HIV organism there were many other possible reasons for the echocardiographic abnormalities. Among AIDS patients there was a high incidence of intravenous drug and alcohol abuse, patients in whom cardiac abnormalities were common.
Since there were no echocardiographic studies comparing HIV antibody- positive groups of patients to appropriate controls, it was not known whether the high reported incidence of echocardiographic abnormalities was related specifically to the HIV infection, to superinfection with other organisms, or was related to factors other than AIDS.
This project was part of an Institute-initiated study on AIDS-Associated Heart Disease in Adults. In September 1987 the concept was approved by the National Heart, Lung, and Blood Advisory Council and a Request for Applications was released. Awards were made in July 1988.
DESIGN NARRATIVE:
Patients were recruited from the in-patient out-patient clinics and wards of the San Francisco General Hospital and the Moffitt-Long Hospitals. A medical history was obtained and a physical examination conducted which included an electrocardiogram, chest x-rays and Doppler echocardiogram. All studies were repeated every four months for four years in HIV-positive groups. If clinical evidence of cardiac disease appeared, all studies including chest x-ray were repeated at that time. If there was normal systolic function in patients with definite left ventricular failure, a radionuclide angiogram was obtained to further evaluate left ventricular diastolic function.
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
Heart Diseases, Acquired Immunodeficiency Syndrome, Myocardial Diseases, 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
1854491
Citation
Kuecherer HF, Kee LL, Modin G, Cheitlin MD, Schiller NB. Echocardiography in serial evaluation of left ventricular systolic and diastolic function: importance of image acquisition, quantitation, and physiologic variability in clinical and investigational applications. J Am Soc Echocardiogr. 1991 May-Jun;4(3):203-14. doi: 10.1016/s0894-7317(14)80020-5.
Results Reference
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PubMed Identifier
7586308
Citation
Heidenreich PA, Eisenberg MJ, Kee LL, Somelofski CA, Hollander H, Schiller NB, Cheitlin MD. Pericardial effusion in AIDS. Incidence and survival. Circulation. 1995 Dec 1;92(11):3229-34. doi: 10.1161/01.cir.92.11.3229.
Results Reference
background
PubMed Identifier
8386905
Citation
Brown DL, Sather S, Cheitlin MD. Reversible cardiac dysfunction associated with foscarnet therapy for cytomegalovirus esophagitis in an AIDS patient. Am Heart J. 1993 May;125(5 Pt 1):1439-41. doi: 10.1016/0002-8703(93)91023-8. No abstract available.
Results Reference
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AIDS-Associated Heart Disease -- Incidence and Etiology
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