HIV-HEART Aging Study

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 2022 (15 year Follow-up) 1858 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 (optional) Exercise electrocardiogram (optional) Exercise Montreal Cognitive Assessment test (optional) Exercise the Grooved Pegboard test (optional) Blood and stool sample collection (optional) 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: 15 Year Follow up

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

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 |
| --- | --- | --- |
| Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection | Calculation of the Framingham Risk Score. It was assumed, that in the next 10 years the individual cardiovascular risk varies between maximal 20% and minimal 0%. | Baseline up to 15 year follow up | 
| Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection | Calculation of Odds Ratio | Baseline up to 15 year follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on cardiovascular risk on amount of atherosclerosis | in relation to age, gender and classic cardiovascular rsik factors inter alia smoking, diabetes, hypercholesterinaemia and arterial hypertension by calculating the relative risk | Baseline up to 15 year follow up | 
| Impact on life quality | in relation to HIV-specfic cardiovascular rsik factors including inter alia virus load (copies/ml) in combination with CD4-count and duration of HV-Infection by calculating the standard deviation | Baseline up to 15 year follow up | 
| Impact on life quality | in relation to HIV-specfic cardiovascular rsik factors including inter alia CD4-count (cells/mm3) in combination with virus load and duration of HIV-infection by calculating the standard deviation | Baseline up to 15 year follow up | 
| Impact on life quality | in relation to HIV-specfic cardiovascular rsik factors including inter alia duration of HIV-Infection (in years) in combination with virus load and CD4-count by calculating the standard deviation | Baseline up to 15 year follow up | 
| Impact on cardiovascular risk, amount of atherosclerosis and life quality | in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval | Baseline up to 15 year follow up | 

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