AIDS-Associated Cardiomyopathy

Completed

• Conditions: Heart Diseases; Acquired Immunodeficiency Syndrome; HIV Infections; Myocardial Diseases

• Registration Number: NCT00005227
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

To define the incidence and prevalence of AIDS-associated cardiomyopathy. Also, to conduct immunopathology and serologic studies in endomyocardial biopsies and autopsy tissues.

Detailed Description

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.

Study Timeline

• Study Start: 1988-07
• Study Completion: 1993-06
• Study First Submitted: 2000-05-25
• Study First Submitted QC: 2000-05-25
• Study First Posted: 2000-05-26
• Status Verified: 2005-03
• Last Update Submitted: 2016-02-17
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified