Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005228
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2000-05-25
Brief Title:
AIDS-Associated Heart Disease -- Incidence and Etiology
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL041495 | NIH | None | httpsreporternihgovquickSearchR01HL041495 |