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

This study has been completed.
Sponsor:
Collaborator:
Federal Ministry of Education and Reserach (BMBF)
Information provided by:
University Hospital, Essen
ClinicalTrials.gov Identifier:
NCT01119729
First received: May 7, 2010
Last updated: NA
Last verified: May 2010
History: No changes posted
  Purpose

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
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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by University Hospital, Essen:

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


Enrollment: 803
Groups/Cohorts
HIV-infected Outpatients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01119729

Locations
Germany
Department of Dermatology, University Hospital of Bochum
Bochum, NRW, Germany, 44791
HIV Outpatient Department
Dortmund, NRW, Germany, 44137
HIV Outpatient Department
Duisburg, NRW, Germany, 47259
HIV Outpatients Department
Duisburg, NRW, Germany, 47055
Department of Dermatology, University Hospital of Essen
Essen, NRW, Germany, 45122
HIV Outpatient Department
Essen, NRW, Germany, 45127
West German Heart Center Essen
Essen, NRW, Germany, 45122
Sponsors and Collaborators
University Hospital, Essen
Federal Ministry of Education and Reserach (BMBF)
  More Information

Publications:
Additional 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
Study First Received: May 7, 2010
Last Updated: May 7, 2010
Health Authority: Germany: Federal Ministry of Education and Reserach (BMBF) represented by the DLR Project Agency

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

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

ClinicalTrials.gov processed this record on November 25, 2014