Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005229
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Brief Title:
HIV-Associated Heart Disease
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 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
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
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 |
|---|---|---|---|
| R01HL041507 | NIH | None | httpsreporternihgovquickSearchR01HL041507 |