Completed

AIDS-Associated Cardiomyopathy

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: In 1988, the leading cause of death in AIDS patients was respiratory mechanisms might have played a significant role in its pathogenesis. The 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: The prevalence study was one of three subprojects with the common failure due to chronic opportunistic pulmonary infection, primarily Pneumocystis carinii pneumonia. Drugs such as azidothymidine (AZT) and trimetrexate showed some effectiveness in prolonging the lives of some AIDS patients. With increased survival, it was believed that cardiac diseases might well become an important complication of AIDs. Reports described a syndrome of rapidly progressive cardiomyopathy associated with AIDS. The etiology of AIDS-associated cardiomyopathy was yet unknown although immunologic theme of the immunopathogenesis of AIDS-associated cardiomyopathy. The other two subprojects dealt with immunopathology studies in endomyocardial biopsies and autopsy tissues and serologic studies. The AIDS Clinical Research Center at Johns Hopkins Hospital served as the source of patients. All patients underwent serologic testing and echocardiography at time of entry and at six and twelve months. The screening electrocardiogram identified 40 to 50 patients per year with AIDS-associated cardiomyopathy. Approximately 30 patients per year had no contraindications for endomyocardial biopsy. Comprehensive tissue studies and cellular immune studies were performed on the cohort and autopsies, if possible. Immunohistochemical techniques and in situ hybridization of biopsy and autopsy material were used to determine if AIDS-associated cardiomyopathy was associated with HIV infection of the heart or with some other viral or opportunistic non-viral infection. Indirect immunofluorescence and a Western immunoblotting assay using patient sera determined the prevalence of heart autoimmunity. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

NCT00005227
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 DiseasesCardiovascular DiseasesCommunicable DiseasesImmunologic Deficiency SyndromesImmune System DiseasesInfectionsRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHeart 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