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Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01667068
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : October 28, 2014
HIV-HEART Study Investigative Group
German Heart Failure Network
German Federal Ministry of Education and Research
Bristol-Myers Squibb
ViiV Healthcare
Gilead Sciences
Janssen-Cilag GmbH
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stefan Esser M.D., University Hospital, Essen

Brief Summary:

Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing.

This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients.

Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and heart valve disorders. In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

Condition or disease Intervention/treatment
Coronary Heart Disease Heart Failure HIV AIDS Metabolic Syndrome Other: Comprehensive non invasive cardiovascular examination

Detailed Description:
A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

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Study Type : Observational
Actual Enrollment : 1481 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: HIV-HEART STUDY: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk in HIV-infected Patients
Study Start Date : April 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort Intervention/treatment
Regional Ruhrgebiets Cohort
HIV-positive patients in the German Ruhr-Region from out-patient clinics of hospitals and HIV-physicians pratices
Other: Comprehensive non invasive cardiovascular examination
  • Anamnesis with the participian
  • File recherche,Physical examination
  • Documentation of the carciovascular and antiretroviral medical therapy
  • Electrocardiogram
  • Transthoracic echocardiography
  • Exercise electrocardiogram
  • Measuring of the arterial media thickness
  • Exercise Montreal Cognitive Assesment test
  • Exercise the Grooved Pegboard test
  • Blood collection
  • Questionnaire to quality of life and health economics

Primary Outcome Measures :
  1. Cardiovascular Diseases in HIV-infected Patients [ Time Frame: Baseline up to 7.5 follow-up to ]
    The detection of prevalence, aetiology, progression and severity of cardiovascular diseases - especially of coronary artery disease in HIV-infected patients.

Secondary Outcome Measures :
  1. Cardiovascular Disorders in HIV-infected Patients HIV-HEART [ Time Frame: Baseline up to 5 years follow-up ]
    Complementary the study also investigates the impact of classic cardiovascular risk factors like gender, age, blood fat and also new HIV-specific risk factors of coronary artery disease like viral-load, CD4-cell count and stage of the infection. The HIV-HEART study will focus the impact of medication including cardiovascular and antiretroviral medication. Further secondary objectives will be examined, including economic costs and the subjectively quality of life of subjects with and without cardiovascular diseases in this patient population.

Biospecimen Retention:   Samples With DNA
Stored blood samples

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participiants were included in several cities of the Ruhrarea. Locations were Essen, Bochum, Dortmund and Duisburg 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. Written informed consent was obtained from all participants.

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute cardiovascular disease
  • Unstable hemodynamic status in the three weeks before inclusion
  • Pregnancy

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 identifier (NCT number): NCT01667068

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University Hospital of Bochum, Department of Dermatology
Bochum, Germany, 44791
HIV Outpatient Department
Dortmund, Germany, 44137
Health Center
Duisburg, Germany, 47249
University Hospital, Department of Dermatology and Venerology
Essen, Germany, 45147
University Hospital, West German Heart Center Essen
Essen, Germany, 45147
Clinical Coordinating Center Leipzig
Leipzig, Germany, 04107
Sponsors and Collaborators
University Hospital, Essen
HIV-HEART Study Investigative Group
German Heart Failure Network
German Federal Ministry of Education and Research
Bristol-Myers Squibb
ViiV Healthcare
Gilead Sciences
Janssen-Cilag GmbH
Boehringer Ingelheim
Merck Sharp & Dohme Corp.
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Principal Investigator: Stefan Esser, MD University Hospital, Essen
Principal Investigator: Till Neumann Neumann, MD University Hospital, Essen
Publications of Results:

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Responsible Party: Stefan Esser M.D., Academic Director, University Hospital, Essen Identifier: NCT01667068    
Other Study ID Numbers: 12-4970-BO
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Stefan Esser M.D., University Hospital, Essen:
Cardiac Diseases
Antiretroviral Therapy
Cardiovascular Medication
Risk Factors
coronary heart disease
heart failure
metabolic syndrome
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Failure
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Arterial Occlusive Diseases