The Open Clinical Trials Journal




(Discontinued)

ISSN: 1876-8210 ― Volume 4, 2013

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
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

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).

Keywords: Cardiac diseases, human immunodeficiency virus, antiretroviral therapy, atherosclerosis.


Article Information


Identifiers and Pagination:

Year: 2010
Volume: 2
First Page: 1
Last Page: 7
Publisher Id: TOCTJ-2-1
DOI: 10.2174/1876821001001020001

Article History:

Received Date: 20/6/2010
Revision Received Date: 2/8/2010
Acceptance Date: 2/9/2010
Electronic publication date: 5/11/2010
Collection year: 2010

© Neumann et al.; Licensee Bentham Open.

open-access license: This is an open access article licensed under the terms of the Creative Commons Attribution Non-Commercial License (http: //creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted, non-commercial use, distribution and reproduction in any medium, provided the work is properly cited.


* 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



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