Completed

HIV-Associated Heart Disease

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Who is being recruted

Blood-Borne Infections+16

+ Urogenital Diseases

+ Genital Diseases

Until 100 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: July 1988
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: February 18, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1988

Actual date on which the first participant was enrolled.

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

NCT00005229
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: February 18, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Until 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeCardiovascular DiseasesHeart DiseasesCardiomyopathiesHIV Infections

Criteria

No eligibility criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available.
CompletedNo study centers