Aging, Coronary Heart Disease, Heart Failure, HIV-encephalopathy, HIV-infection, Myocardial Infarction
Conditions
Keywords
HIV, AIDS, antiretroviral therapy, aging, heart failure, coronary heart disease, myocardial infarction, HIV-associated neurocognitive disorders
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.
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
Interventions
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
Sponsors
University Hospital, Essen
Nico Reinsch M. D.
Till Neumann Prof. M. D.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cardiovascular Diseases an deaths in HIV-infected Patients | Baseline up to 10 year follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of classic cardiovascular risk factors and new HIV-specific risk factors of coronary artery disease, comorbidities and antiretroviral therapy | 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. |
Countries
Germany
Outcome results
None listed