HIV&HEART Aging Study (12,5 Year Follow up)

Study Overview
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Brief Summary
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The HIV/HEART Aging 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 October 2019 (12,5 year Follow-up) 1806 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.

Detailed Description
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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

Official Title
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A Prospective, Epidemiologic and Multicentre Trial to Determine the Cardiovascular Risk, New Cardiovascular Events and the Cardiovascular Diseases in HIV-infected Patients: 12,5 Year Follow up

Conditions
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Aging, HIV Infections, Coronary Disease, Myocardial Infarction, HIV Encephalopathy, Heart Failure

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Known HIV-infection Signed informed consent Exclusion Criteria: Acute cardiovascular disease Unstable hemodynamic status in the three weeks before inclusion Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Diseases in HIV-infected Patients |  | Baseline up to 12,5 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of classic cardiovascular risk factors of coronary artery disease, comorbidities and antiretroviral therapy |  | Baseline up to 12,5 year follow up | 
| Impact of new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy |  | Baseline up to 12,5 year follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, Antiretroviral therapy, Aging, Heart failure, coronary heart disease, myocardial infarction, HIV-associated neurocognitive disorders