AIDS-Associated Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005227
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: March 2005
  Purpose

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


Condition
Acquired Immunodeficiency Syndrome
Heart Diseases
Myocardial Diseases
HIV Infections

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: July 1988
Estimated Study Completion Date: June 1993
Detailed Description:

BACKGROUND:

In 1988, the leading cause of death in AIDS patients was respiratory 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 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 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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00005227

Sponsors and Collaborators
Investigators
Investigator: Ahvie Herskowitz Johns Hopkins University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005227     History of Changes
Other Study ID Numbers: 1107
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
Cardiomyopathies
Heart Diseases
HIV Infections
Immunologic Deficiency Syndromes
Cardiovascular Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 28, 2014