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

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ClinicalTrials.gov Identifier: NCT01119729
Recruitment Status : Completed
First Posted : May 10, 2010
Last Update Posted : May 10, 2010
Sponsor:
Collaborator:
Federal Ministry of Education and Reserach (BMBF)
Information provided by:
University Hospital, Essen

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection. Effect on Cardiovascular Risk and Life Quality by Age, Gender, Classic Cardiovascular Risk Factors, HIV-specific Cardiovascular Risk Factors, Cardiovascular Medication, Antiretroviral Medication

Study Design
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Study Type : Observational
Actual Enrollment : 803 participants
Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
HIV-infected Outpatients


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Prevalence of cardiovascular disorders
    Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Criteria

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

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119729


Locations
Germany
Department of Dermatology, University Hospital of Bochum
Bochum, NRW, Germany, 44791
HIV Outpatient Department
Dortmund, NRW, Germany, 44137
HIV Outpatients Department
Duisburg, NRW, Germany, 47055
HIV Outpatient Department
Duisburg, NRW, Germany, 47259
Department of Dermatology, University Hospital of Essen
Essen, NRW, Germany, 45122
West German Heart Center Essen
Essen, NRW, Germany, 45122
HIV Outpatient Department
Essen, NRW, Germany, 45127
Sponsors and Collaborators
University Hospital, Essen
Federal Ministry of Education and Reserach (BMBF)
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: PD Dr. med. Till Neumann, FESC, Competence Network of Heart Failure
ClinicalTrials.gov Identifier: NCT01119729     History of Changes
Other Study ID Numbers: FKZ 01GI0205
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: May 10, 2010
Last Verified: May 2010

Keywords provided by University Hospital, Essen:
Cardiac Diseases • HIV-Infection • AIDS • Antiretroviral Therapy

Additional relevant MeSH terms:
HIV Infections
Cardiovascular Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
 Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases