HIV-HEART Aging Study (15 Year Follow up)
Study Details
Study Description
Brief Summary
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) 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.
| Condition or Disease | Intervention/Treatment | Phase |
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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
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Anamnesis
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File recherche,Physical examination
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Documentation of the cardiovascular and antiretroviral medical therapy
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Electrocardiogram
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Transthoracic echocardiography
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Exercise electrocardiogram
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Exercise Montreal Cognitive Assessment test
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Exercise the Grooved Pegboard test
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Blood and stool sample collection
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Questionnaire to quality of life and health economics
Study Design
Outcome Measures
Primary Outcome Measures
- Detection of frequency, severity of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection [Baseline up to 15 year follow up]
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%.
- Detection of progression of cardiovascular diseases - especially of coronary artery disease - in patients with HIV-Infection [Baseline up to 15 year follow up]
Calculation of Odds Ratio
Secondary Outcome Measures
- Impact on cardiovascular risk on amount of atherosclerosis [Baseline up to 15 year follow up]
in relation to age, gender and classic cardiovascular rsik factors inter alia smoking, diabetes, hypercholesterinaemia and arterial hypertension by calculating the relative risk
- Impact on life quality [Baseline up to 15 year follow up]
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
- Impact on life quality [Baseline up to 15 year follow up]
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
- Impact on life quality [Baseline up to 15 year follow up]
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
- Impact on cardiovascular risk, amount of atherosclerosis and life quality [Baseline up to 15 year follow up]
in relation to cardiovascular and antiretroviral medication by calculating the 95%-Confidence interval
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age > 18 years
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Known HIV-infection
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Signed informed consent
Exclusion Criteria:
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Acute cardiovascular disease
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Unstable hemodynamic status in the three weeks before inclusion
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Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut für Medizinische Informatik, Biometrie und Epidemiologie | Essen | Nordrhein-Westfalen | Germany | 45147 |
| 2 | Universitätsklinikum Essen, Klinik für Dermatologie | Essen | Nordrheinwestfalen | Germany | 45147 |
| 3 | HIV physician pratice | Duisburg | NRW | Germany | 47259 |
| 4 | University Hospital of Bochum, Department of Dermatology | Bochum | Germany | 44791 | |
| 5 | HIV Outpatient Department | Dortmund | Germany | 44137 |
Sponsors and Collaborators
- University Hospital, Essen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 14-5874-BO