Recruiting and Baseline of the HIV-HEART Study: A Prospective, Multicenter Trial to Analyze Cardiac Diseases in HIV-Infected Patients

Background: An increased life span and the amount of cardiovascular risk factors necessitate a closer look on cardiac diseases in the population of human immunodeficiency virus (HIV) – infected subjects. Therefore, we launched a cardiology driven study analyzing HIV-associated diseases supported by the federal ministry of research. Methods: The HIV-HEART (HIV-infection and HEART disease) study is a prospective and multicenter cohort study performed in an urban area. The study comprehends standardized non-invasive cardiology tests of cardiac diseases, such as laboratory parameter, electrocardiogram, echocardiography and an endurance testing by a six-minute walk test. Results: In a 20 month recruiting period 802 HIV-infected patients (age: 44,2 ± 10,3 years; male: 83,4%) were included into the HIV-HEART Study. Duration of HIV-infection since initial diagnosis was 7,6 ± 5,8 years. Virus load was in 65,6% less than 50 copies/ml and CD4 - cell count (508,8 ± 300,6 cells/􀀁l) was more than 500 cells/􀀁l in 42,6%. A reduced CD4 – cell count between 200 and 499 cells/􀀁l or less than 200 cells/􀀁l was present in 45% and 12, 4%, respectively. Of all participants, 85,2% received antiretroviral therapy, most of these patients NRTIs (96,8%), followed by PIs (48,5%), and NNRTIs (45,7%). Conclusions: The characteristics of the HIV-HEART Study cohort are comparable to other national or international cohort registers on HIV-infected persons, performed in industrialized countries. Therefore, the HIV-HEART Study will be able to yield reliable data on the performance of HIV-associated diseases. (Clinical Trials NCT01119729).