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A Prospective Observational Trial to Determine Cardiovascular Diseases in HIV-infected Patients (HIV-HEART10)

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.
 
ClinicalTrials.gov Identifier: NCT02291081
Recruitment Status : Completed
First Posted : November 14, 2014
Last Update Posted : October 1, 2019
Sponsor:
Collaborators:
Nico Reinsch M. D.
Till Neumann Prof. M. D.
Information provided by (Responsible Party):
Stefan Esser M.D., University Hospital, Essen

Brief Summary:
The HIV/HEART study (HIVH) is an ongoing, prospective, multicentre trial that was conducted to assess the incidence, the prevalence and the clinical course of cardiovascular diseases (CVD) in HIV-infected patients. The study population includes outpatients from specialized HIV-care units of the German Ruhr region, who were at least 18 years of age, were known to have a HIV-infection and exhibited a stable disease status within 4 weeks before inclusion into the trial. From March 2004 (Pilot phase) to May 2014 (7,5 year Follow-up) 1481 HIV+ patients were recruited in a consecutive manner. The standardised examinations included a targeted assessment of medical history and physical examination. Blood was drawn for comprehensive laboratory tests including HIV specific parameters (CD4 cell count, HIV-1 RNA levels) and cardiovascular items (lipid concentrations, BNP values and renal parameters). Furthermore, non-invasive tests were performed during the initial visit, including additional heart rate and blood pressure measurements, electrocardiogram (ECGs) and transthoracic echocardiography (TTE). Examinations were completed in accordance with previously defined standard operating procedures. CVD were defined as coronary, cerebrovascular, peripheral arterial disease, heart failure or cardiac vitium.

Condition or disease Intervention/treatment
HIV-infection Coronary Heart Disease Myocardial Infarction HIV-encephalopathy Heart Failure Aging 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).

Comprehensive non invasive cardiovascular examination

  • Anamnesis
  • File recherche,Physical examination
  • Documentation of the cardiovascular and antiretroviral medical therapy
  • Electrocardiogram
  • Transthoracic echocardiography
  • Exercise electrocardiogram
  • Exercise Montreal Cognitive Assessment test
  • Exercise the Grooved Pegboard test
  • Blood collection
  • Questionnaire to quality of life and health economics

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Study Type : Observational
Actual Enrollment : 1519 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 10 Year Follow-up
Study Start Date : October 2014
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS


Intervention Details:
  • Other: Comprehensive non invasive cardiovascular examination

    Comprehensive non invasive cardiovascular examination

    • Anamnesis with the participants
    • File recherche,Physical examination
    • Documentation of the cardiovascular and antiretroviral medical therapy
    • Electrocardiogram
    • Transthoracic echocardiography
    • Exercise electrocardiogram
    • Exercise Montreal Cognitive Assessment test
    • Exercise the Grooved Pegboard test
    • Blood collection
    • Questionnaire to quality of life and health economics


Primary Outcome Measures :
  1. Cardiovascular Diseases an deaths in HIV-infected Patients [ Time Frame: Baseline up to 10 year follow-up ]

Secondary Outcome Measures :
  1. Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy [ Time Frame: Baseline up to 10 year follow-up ]
    Patients included in the pilot-baseline trial and additionally in the 5 and 7.5 year follow-up will be recruited again for the 10 year follow-up after giving informed consent. After including a total of 1481 patients in the previous phases, now both therapy-naive patients as well as patients being treated with new agents should be included.


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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT02291081


Locations
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Germany
University Hospital of Bochum, Department of Dermatology
Bochum, NRW, Germany, 44791
City Hospital Dortmund
Dortmund, NRW, Germany, 44137
HIV physician pratice
Duisburg, NRW, Germany, 47259
University Hospital, Department of Dermatology and Venerology
Essen, NRW, Germany, 45122
HIV physician practice
Essen, NRW, Germany, 45136
HIV physician practice
Krefeld, NRW, Germany, 47799
Clinical Coordinating Center Leipzig
Leipzig, Sachsen, Germany, 04107
Sponsors and Collaborators
University Hospital, Essen
Nico Reinsch M. D.
Till Neumann Prof. M. D.
Investigators
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Principal Investigator: Stefan Esser, MD Depatment of dermatology and venerology
Publications of Results:

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Responsible Party: Stefan Esser M.D., Academic director, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT02291081    
Other Study ID Numbers: 12-4970-BO A
First Posted: November 14, 2014    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Keywords provided by Stefan Esser M.D., University Hospital, Essen:
HIV, AIDS
antiretroviral therapy
aging
heart failure
coronary heart disease
myocardial infarction
HIV-associated neurocognitive disorders
Additional relevant MeSH terms:
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AIDS Dementia Complex
Brain Diseases
Heart Failure
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Infarction
Ischemia
Pathologic Processes
Necrosis
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Central Nervous System Diseases
Nervous System Diseases
Dementia
Neurocognitive Disorders
Mental Disorders