Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)

May 7, 2010 updated by: University Hospital, Essen
Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV-infected patients in the majority treated with antiretroviral drugs, the investigators still do not know much about the impact of cardiovascular diseases in this group of patients. The present study is an ongoing trial that was conducted as a prospective and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac disorders in HIV-infected patients.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

803

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Bochum, NRW, Germany, 44791
        • Department of Dermatology, University Hospital of Bochum
      • Dortmund, NRW, Germany, 44137
        • HIV Outpatient Department
      • Duisburg, NRW, Germany, 47055
        • HIV Outpatients Department
      • Duisburg, NRW, Germany, 47259
        • HIV Outpatient Department
      • Essen, NRW, Germany, 45122
        • Department of Dermatology, University Hospital of Essen
      • Essen, NRW, Germany, 45122
        • West German Heart Center Essen
      • Essen, NRW, Germany, 45127
        • HIV Outpatient Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Patients were recruited during a 20-month period in a consecutive manner from September 2004 to May 2006. Written informed consent was obtained from all participants

Description

Inclusion Criteria:

  • Age > 18 years
  • Known HIV-infection
  • Outpatients
  • Written informed consent

Exclusion Criteria:

● Acute cardiovascular disease or unstable hemodynamic status in the three weeks before inclusion

• Pregnancy

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HIV-infected Outpatients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Prevalence of cardiovascular diseases
Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases.

Secondary Outcome Measures

Outcome Measure
Measure Description
Prevalence of cardiovascular disorders
Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Collaborators

Federal Ministry of Education and Reserach (BMBF)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

May 10, 2010

Last Update Submitted That Met QC Criteria

May 7, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKZ 01GI0205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection.

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