Recruiting and Baseline of the HIV-HEART Study: A Prospective, Multicenter Trial to Analyze Cardiac Diseases in HIV-Infected Patients
Till Neumann*, 1, Andreas Sundermeyer1, Stefan Esser2, Anja Potthoff3, Martin Hower4, Ingulf Becker-Boost 5, Birgit Ross2, Robert Jablonka2, Katrin Neuhaus1, Anja Neumann6, Nico Reinsch1, Rolf Wachter7, Thomas Müller-Tasch8, Felix Mehrhof9, Christiane Prettin10, Götz Gelbrich10, Bernhard Maisch11, Norbert Brockmeyer3, Jürgen Wasem6, Rainer Dietz9, Raimund Erbel1Author Comment: for the HIV-HEART Study Investigative Group on Behalf of the German Competence Network of Heart Failure and German Competence Network for HIV/AIDS
1 Departments of Cardiology
3 University Hospital Essen,the Department of Dermatology
4 University Hospital Bochum, HIV-Outpatient Clinic, Dortmund
6 the Alfried Krupp von Bohlen und Halbach Foundation-Institute for Health Systems Management
7 University of Duisburg-Essen, the Department of Cardiology
8 University Hospital Göttingen, Department of Psychosomatic and General Internal Medicine
9 University Hospital Heidelberg,the Department of Cardiology
10 Charite, University Hospital Berlin, Clinical Trials Centre Leipzig, University of Leipzig
11 University of Leipzig, the Department of Cardiology
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.
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.
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/µl) was more than 500 cells/µl in 42,6%. A reduced CD4 – cell count between 200 and 499 cells/µl or less than 200 cells/µl 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%).
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).
Keywords: Cardiac diseases, human immunodeficiency virus, antiretroviral therapy, atherosclerosis.
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* Address correspondence to this author at the Department of Cardiology, University of Duisburg-Essen, Medical School, Hufelandstr. 55, D-45122 Essen, Germany; Tel: ++49 (0)201 723 4806; Fax: ++49 (0)201 723 5488; E-mail: firstname.lastname@example.org