The Open Clinical Trials Journal
2010, 2 : 1-7Published online 2010 November 5. DOI: 10.2174/1876821001001020001
Publisher ID: TOCTJ-2-1
RESEARCH ARTICLE
Recruiting and Baseline of the HIV-HEART Study: A Prospective, Multicenter Trial to Analyze Cardiac Diseases in HIV-Infected Patients
2 Dermatology
3 University Hospital Essen,the Department of Dermatology
4 University Hospital Bochum, HIV-Outpatient Clinic, Dortmund
5 Duisburg
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
* 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: till.neumann@uni-essen.de
ABSTRACT
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/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%).
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).