Cardiovascular Diseases in HIV-infected Subjects (HIV-HEART Study)

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ClinicalTrials.gov Identifier: NCT01119729

Recruitment Status : Completed

First Posted : May 10, 2010

Last Update Posted : May 10, 2010

Sponsor:

Collaborator:

Federal Ministry of Education and Reserach (BMBF)

Information provided by:

University Hospital, Essen

Study Description

Brief Summary:

Human immunodeficiency virus (HIV) infection has been associated with a variety of cardiovascular diseases. Even most industrialised countries exhibit a growing and aging population of HIV-infected patients in the majority treated with antiretroviral drugs, the investigators still do not know much about the impact of cardiovascular diseases in this group of patients. The present study is an ongoing trial that was conducted as a prospective and multicentre survey, being schemed to analyse the frequency and clinical course of cardiac disorders in HIV-infected patients.

Condition or disease
Detection of Frequency, Severity and Progression of Cardiovascular Diseases in Patients With HIV-infection. Effect on Cardiovascular Risk and Life Quality by Age, Gender, Classic Cardiovascular Risk Factors, HIV-specific Cardiovascular Risk Factors, Cardiovascular Medication, Antiretroviral Medication

Study Design

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Study Type :	Observational
Actual Enrollment :	803 participants
Observational Model:	Cohort
Time Perspective:	Prospective

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
HIV-infected Outpatients

Outcome Measures

Primary Outcome Measures :

Prevalence of cardiovascular diseases
Prevalence of cardiovascular diseases including coronary artery disease, congestive heart failure, peripheral arterial disease, cerebrovascular events, and valvular diseases.

Secondary Outcome Measures :

Prevalence of cardiovascular disorders
Prevalence of cardiovascular disorders determined by electrocardiography, exercise testing, echocardiography, blood samples.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Sampling Method:	Non-Probability Sample

Study Population

The study population included outpatients who were at least 18 years of age, had a known HIV-infection and exhibited a stable disease status within 4 weeks before inclusion of the trial. Patients were recruited during a 20-month period in a consecutive manner from September 2004 to May 2006. Written informed consent was obtained from all participants

Criteria

Inclusion Criteria:

Age > 18 years
Known HIV-infection
Outpatients
Written informed consent

Exclusion Criteria:

● Acute cardiovascular disease or unstable hemodynamic status in the three weeks before inclusion

• Pregnancy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119729

Locations

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Germany
Department of Dermatology, University Hospital of Bochum
Bochum, NRW, Germany, 44791
HIV Outpatient Department
Dortmund, NRW, Germany, 44137
HIV Outpatients Department
Duisburg, NRW, Germany, 47055
HIV Outpatient Department
Duisburg, NRW, Germany, 47259
Department of Dermatology, University Hospital of Essen
Essen, NRW, Germany, 45122
West German Heart Center Essen
Essen, NRW, Germany, 45122
HIV Outpatient Department
Essen, NRW, Germany, 45127

Sponsors and Collaborators

University Hospital, Essen

Federal Ministry of Education and Reserach (BMBF)

More Information

Publications of Results:

Neumann T. [HIV, AIDS and the cardiovascular risk]. Internist (Berl). 2008 Apr;49(4):429-30, 432-5. doi: 10.1007/s00108-008-2049-4. Review. German.

Reinsch N, Buhr C, Krings P, Kaelsch H, Kahlert P, Konorza T, Neumann T, Erbel R; Competence Network of Heart Failure. Effect of gender and highly active antiretroviral therapy on HIV-related pulmonary arterial hypertension: results of the HIV-HEART Study. HIV Med. 2008 Aug;9(7):550-6. doi: 10.1111/j.1468-1293.2008.00602.x. Epub 2008 Jun 28.

Reinsch N, Buhr C, Krings P, Kaelsch H, Neuhaus K, Wieneke H, Erbel R, Neumann T; German Heart Failure Network. Prevalence and risk factors of prolonged QTc interval in HIV-infected patients: results of the HIV-HEART study. HIV Clin Trials. 2009 Jul-Aug;10(4):261-8. doi: 10.1310/hct1004-261.

Neumann T, Reinsch N, Neuhaus K, Brockmeyer N, Potthoff A, Esser S, Hower M, Neumann A, Mostardt S, Gelbrich G, Erbel R; für die HIV-HEART-Studie sowie die Kompetenznetze Herzinsuffizienz und HIV/AIDS. [BNP in HIV-infected patients]. Herz. 2009 Dec;34(8):634-40. doi: 10.1007/s00059-009-3313-7. German.

Other Publications:

Neumann T, Esser S, Potthoff A, Pankuweit S, Neumann A, Breuckmann F, Neuhaus K, Kondratieva J, Buck T, Müller-Tasch T, Wachter R, Prettin C, Gelbrich G, Herzog W, Pieske B, Rauchhaus M, Löffler M, Maisch B, Mügge A, Wasem J, Gerken G, Brockmeyer NH, Erbel R; HIV-HEART Study Investigative Group. Prevalence and natural history of heart failure in outpatient HIV-infected subjects: rationale and design of the HIV-HEART study. Eur J Med Res. 2007 Jun 27;12(6):243-8.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Reinsch N, Esser S, Gelbrich G, Brockmeyer N, Potthoff A, Schadendorf D, Erbel R, Neumann T. Valvular manifestations of human immunodeficiency virus infection--results from the prospective, multicenter HIV-HEART study. J Cardiovasc Med (Hagerstown). 2013 Oct;14(10):733-9. doi: 10.2459/JCM.0b013e32835dc953.

Esser S, Gelbrich G, Brockmeyer N, Goehler A, Schadendorf D, Erbel R, Neumann T, Reinsch N. Prevalence of cardiovascular diseases in HIV-infected outpatients: results from a prospective, multicenter cohort study. Clin Res Cardiol. 2013 Mar;102(3):203-13. doi: 10.1007/s00392-012-0519-0. Epub 2012 Nov 2.

Reinsch N, Kahlert P, Esser S, Sundermeyer A, Neuhaus K, Brockmeyer N, Potthoff A, Erbel R, Buck T, Neumann T. Echocardiographic findings and abnormalities in HIV-infected patients: results from a large, prospective, multicenter HIV-heart study. Am J Cardiovasc Dis. 2011;1(2):176-84. Epub 2011 Jul 30.

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Responsible Party:	PD Dr. med. Till Neumann, FESC, Competence Network of Heart Failure
ClinicalTrials.gov Identifier:	NCT01119729
Other Study ID Numbers:	FKZ 01GI0205
First Posted:	May 10, 2010 Key Record Dates
Last Update Posted:	May 10, 2010
Last Verified:	May 2010

Keywords provided by University Hospital, Essen:


Cardiac Diseases • HIV-Infection • AIDS • Antiretroviral Therapy

Additional relevant MeSH terms:

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HIV Infections Cardiovascular Diseases Lentivirus Infections Retroviridae Infections RNA Virus Infections	Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases

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