An observational study in HIV Infections, Coronary Disease and Myocardial Infarction, sponsored by University Hospital, Essen. Recruiting at 5 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by University Hospital, Essen · Observational
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.
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
41 studies on the registry are indexed under AIDS Dementia Complex; 2 are open to participants now.
Browse AIDS Dementia Complex studies →University Hospital, Essen is the lead sponsor of 118 studies on the registry; 35 are open to participants now.
Compared within AIDS Dementia Complex, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is HIV Infections. The counts are of registry records indexed under each term, refreshed daily. How we classify →
population affected by HIV
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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%.
Time frame: 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
Time frame: Baseline up to 15 year follow up
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to 15 year follow up
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